Journal: Diabetes/Metabolism Research and Reviews

OBJECTIVE: To assess the relationship between the site, ischaemia, neuropathy, bacterial infection, area, depth (SINBAD) score and major adverse foot events in patients with diabetes and foot ulcers.

METHODS: For this retrospective ancillary study, patients (n = 537) followed for a diabetic foot ulcer (DFU) in six French hospitals were included between 1 February 2019 and 17 March 2019, and between 1 February 2020 and 17 March 2020. The SINBAD score was assessed at inclusion. The frequency of a composite outcome consisting of eight major adverse foot events (MAFE) was assessed after 5-6 months of follow-up: hospitalisation for DFU, septic surgery, revascularisation, minor amputation, major amputation, death, secondary infection and ulcer recurrence. A logistical regression explored the link between the SINBAD score and MAFE and each of its component.

RESULTS: A low SINBAD score (from 0 to 3) was observed in 61% of patients and a high (from 4 to 6) in 39%. MAFE occurred in, respectively, 24% and 28% of these patients. Multivariate analyses showed a significant relationship between the SINBAD score and MAFE, with the continuous SINBAD score: odds ratio (OR) 1.72 [95% CI (1.51-1.97)] or dichotomic SINBAD score (values: 0-3 and 4-6): OR 3.71 [95% CI (2.54-5.42)]. The SINBAD score (continuous or dichotomic) at inclusion was also significantly associated with six out of the eight components of the MAFE.

CONCLUSIONS: The SINBAD score is a useful tool for predicting major adverse foot events.

© 2023 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.

Journal: The International Journal of Lower Extremity Wounds

Diabetic foot infection (DFI) is a common problem in patients with diabetic foot disease. Amputations and other complications of DFI lead to significant morbidity and mortality. The Society for Vascular Surgery (SVS)-WIfI (wound, ischemia, and foot infection) classification system can evaluate the benefit from revascularization and the risk of amputation in 1 and 3 years. We aimed to evaluate SVS-WIfI and Wagner-Meggitt (WM) prediction of DFI outcome, and to determine factors associated with major amputation and mortality rate. The patients with diabetes who presented between June 2018 and May 2020 with characteristics suggesting a more serious DFI or potential indications for hospitalization were reviewed in this cohort study. Demographic data, clinical characteristics, and type of revascularization were evaluated. One-year and 3-year amputation and mortality rates were the main outcomes. The grading of WM classification and the SVS-WIfI score were compared between amputation and nonamputation groups. Association between mortality and comorbidity were analyzed. One hundred and thirty-one patients admitted with DFI were included in study. And 73.28% had peripheral arterial disease (PAD). The 1-year and 3-year major amputation rates were 16.03% and 26.23%, respectively. Seventy-eight (59.54%) patients required minor amputation to control infection before revascularization. PAD (risk ratio [RR] 1.47: 95% confidence interval [CI] 1.29-1.67, P = .032), benefit from revascularization clinical stage 3 on SVS-WIfI score (RR 4.56: 95%CI 1.21-17.21, P = 0.007), and high WM classification score (RR 9.46: 95% CI 5.65-15.82, P <  0.001) were associated by multivariate analysis with high amputation rates. 1-year & 3-year amputation risk on SVS-WIfI score were not associated with amputation rates in DFI (P = .263 and .496). Only 9 (6.8%) patients were lost to follow up during the 3-year period. WM classification score, SVS-WIfI score on benefit from revascularization, and PAD were strongly associated with major amputation rates in patients with DFI.

Journal: Diabetes Care

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

© 2024 by the American Diabetes Association.

Journal: Diabetes Care

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

© 2024 by the American Diabetes Association.

Journal: Diabetes Care

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

© 2024 by the American Diabetes Association.

Journal: Diabetes Care

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

© 2024 by the American Diabetes Association.

Journal: Diabetes Care

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

© 2024 by the American Diabetes Association.

Journal: Diabetes Care

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

© 2024 by the American Diabetes Association.

Journal: Diabetes Care

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

© 2024 by the American Diabetes Association.

Journal: Diabetes Care

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

© 2024 by the American Diabetes Association.

Journal: Scientific Reports

Split-thickness skin grafts (SSG) for wound treatment has drawbacks, including trauma during skin harvesting, limited availability of healthy skin, pain, scarring, and suitability concerns for certain patients. However, "skin cell drop" presents a promising solution. This fully autologous therapy eliminates rejection and contamination risks, while promoting wound healing with platelet-rich plasma (PRP). Harvested from the patient's own skin biopsy in bedside ward setting, these cells seamlessly integrate into the skin, overcoming many limitations of SSG. This study was conducted to determine the adverse effect and wound healing rate of autologous skin cells with PRP (skin cell drop) in diabetic ulcer and trauma injuries. A prospective, single-centre clinical trial was conducted at Hospital Canselor Tuanku Muhriz from December 2021 to December 2022. The study enrolled total of 7 participants, 2 with traumatic wounds and 5 with diabetic ulcers, using random sampling. After obtaining informed consent, a 1 cm2 skin biopsy was harvested from a concealed area. The skin sample was suspended in PRP, and applied to the wound within 4-6 h. Follow-up assessments were conducted at specified intervals up to 12 weeks, evaluating demographics, medical history, wound size, vital signs, visual analog scale (VAS). 7 patients were included in this study with 5 patients were diabetic ulcers while another 2 patients were in trauma wound. No significant difference in the CRP and tWBC after treatment, but significant reduction in VAS pain score were noted as early as 5 days. No significant association between the type of wound (diabetic ulcers or Trauma) and wound healing rate. There is a significant reduction in ulcer size in diabetic ulcers post 21, 35, 49 and 77 days of treatment (p <  0.05). The 'skin cell drop' approach appears safe and effective for treating diabetic ulcers and trauma wounds, with significant reductions in ulcer size. Further research with larger sample sizes and longer follow-up is warranted to validate these results.

© 2025. The Author(s).

Journal: Diabetes Care

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

© 2024 by the American Diabetes Association.

Journal: Diabetes Care

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

© 2024 by the American Diabetes Association.

Journal: Diabetes Care

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

© 2024 by the American Diabetes Association.

Journal: Diabetes Care

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

© 2024 by the American Diabetes Association.

Journal: Diabetes Care

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

© 2024 by the American Diabetes Association.

Journal: Diabetes Care

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

© 2024 by the American Diabetes Association.

Journal:

Diabetes Care is a journal for the health care practitioner that is intended to increase knowledge, stimulate research, and promote better management of people with diabetes.

Journal: Diabetes Care

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

© 2024 by the American Diabetes Association.

Journal: Diabetes Care

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

© 2024 by the American Diabetes Association.

Journal: The Journal of Dermatology

The Japanese Dermatological Association aimed to prepare a second edition of guidelines for the management of diabetic ulcer/gangrene with emphasis on the diagnosis and treatment of skin symptoms. This new edition serves as a tool to improve the quality of the diagnosis and treatment in each patient and, further, to improve the level of care for such skin conditions. All sections have been updated by collecting documents published since the publication of the first edition. In the antibacterial drug treatment for bacterial infection of ulcers, oral administration was added after consideration. In the treatment of antibacterial drugs for bacterial infection of ulcers, not only infusion but also oral administration was mentioned. In addition, clinical questions (CQs) for imaging tests for diagnosing ischemia of the limbs were newly created. The titles of some CQs were changed to conform to the actual clinical setting. (i) The content has been updated by adding and collecting documents for all sections; (ii) we have additionally included oral antibiotic treatment for bacterial infection of ulcers; (iii) we have added CQs pertaining to imaging tests for diagnosing ischemia of the limbs; and (iv) we have revised the titles of some CQs to conform to the actual clinical setting. In particular, the recommendation levels of dressing materials newly covered by Japanese national health insurance are mentioned. In addition, CQs regarding the initial treatment of electrical (CQ15) and chemical burns (CQ16), and the use of escharotomy (CQ22) have been created.

© 2025 Japanese Dermatological Association.

Journal: Infectious diseases now

In march 2020, the International Working Group on the Diabetic Foot (IWGDF) published an update of the 2015 guidelines on the diagnosis and management of diabetic foot infection (DFI). While we (the French ID society, SPILF) endorsed some of these recommendations, we wanted to update our own 2006 guidelines and specifically provide informative elements on modalities of microbiological diagnosis and antibiotic treatment (especially first- and second-line regiments, oral switch and duration). The recommendations put forward in the present guidelines are addressed to healthcare professionals managing patients with DFI and more specifically focused on infectious disease management of this type of infection, which clearly needs a multidisciplinary approach. Staging of the severity of the infection is mandatory using the classification drawn up by the IWGDF. Microbiological samples should be taken only in the event of clinical signs suggesting infection in accordance with a strict preliminarily established protocol. Empirical antibiotic therapy should be chosen according to the IWGDF grade of infection and duration of the wound, but must always cover methicillin-sensitive Staphylococcus aureus. Early reevaluation of the patient is a fundamental step, and duration of antibiotic therapy can be shortened in many situations. When osteomyelitis is suspected, standard foot radiograph is the first-line imagery examination and a bone biopsy should be performed for microbiological documentation. Histological analysis of the bone sample is no longer recommended. High dosages of antibiotics are recommended in cases of confirmed osteomyelitis.

Copyright © 2023 Elsevier Masson SAS. All rights reserved.

Journal:

Significance: The Wound Healing Foundation recognized the need for consensus-based unbiased recommendations for the treatment of wounds. Consensus statements on the treatment of chronic wounds and acute wounds have been developed and published previously. The current publication on diabetic wounds represents the next step in this process. Diabetic wounds constitute a major problem. Population-based and meta-analytic studies indicate that the presence of foot wounds in patients with diabetes increases their mortality risk by more than twofold. The management of diabetic wounds requires consistent and evidence-driven intervention to achieve optimal clinical outcomes. This consensus statement provides the clinician with the necessary foundational approaches to the causes, diagnosis, and therapeutic management of diabetic wounds. Presented in a structured format, this is a useful guide for clinicians and learners in all patient care settings. Recent Advances: Continuous glucose monitoring and other new tools have facilitated better diabetes management and the management of associated wounds. Diabetic limb salvage should focus on achieving and optimizing function for the patient with diabetes rather than preserving limb tissue at all costs. Critical Issues: Successful management of diabetic wounds requires a multidisciplinary approach encompassing comprehensive assessment, timely intervention, and collaborative care by the wound clinician with providers who can address critical aspects to achieve healing, including careful management of blood glucose levels, optimization of off-loading and physical therapy, assessment and treatment of limb ischemia, control and prevention of wound infection, and optimal pain management. Future Directions: Emerging treatments offer hope and promise, but the heterogenicity of diabetic wounds poses a challenge to performing good studies, which will be necessary to advance new treatments for diabetic wounds.

Journal: Advances in wound care

Significance: The Wound Healing Foundation recognized the need for consensus-based unbiased recommendations for the treatment of wounds. Consensus statements on the treatment of chronic wounds and acute wounds have been developed and published previously. The current publication on diabetic wounds represents the next step in this process. Diabetic wounds constitute a major problem. Population-based and meta-analytic studies indicate that the presence of foot wounds in patients with diabetes increases their mortality risk by more than twofold. The management of diabetic wounds requires consistent and evidence-driven intervention to achieve optimal clinical outcomes. This consensus statement provides the clinician with the necessary foundational approaches to the causes, diagnosis, and therapeutic management of diabetic wounds. Presented in a structured format, this is a useful guide for clinicians and learners in all patient care settings. Recent Advances: Continuous glucose monitoring and other new tools have facilitated better diabetes management and the management of associated wounds. Diabetic limb salvage should focus on achieving and optimizing function for the patient with diabetes rather than preserving limb tissue at all costs. Critical Issues: Successful management of diabetic wounds requires a multidisciplinary approach encompassing comprehensive assessment, timely intervention, and collaborative care by the wound clinician with providers who can address critical aspects to achieve healing, including careful management of blood glucose levels, optimization of off-loading and physical therapy, assessment and treatment of limb ischemia, control and prevention of wound infection, and optimal pain management. Future Directions: Emerging treatments offer hope and promise, but the heterogenicity of diabetic wounds poses a challenge to performing good studies, which will be necessary to advance new treatments for diabetic wounds.

Journal: NEJM Evidence

BACKGROUND: Diabetic foot ulcers are chronic, difficult to heal, and potentially life-threatening. Few medical devices have been studied in diabetic ulcers penetrating to bone or tendon.

METHODS: We conducted an international, open-label randomized controlled trial, randomly assigning patients with diabetic ulcers penetrating to bone, joint, or tendon 1:1 to intact fish skin graft or standard wound care, with assigned treatment applied through 14 weeks. The primary end point was the proportion of ulcers healed at 16 weeks, defined as reepithelization as identified by the investigator, and confirmed 14 days later. A blinded adjudication committee confirmed healing at both time points. Healing was also assessed at 20 and 24 weeks.

RESULTS: Between July 2020 and November 2022, 255 patients were randomly assigned to intact fish skin graft (n=129) or standard of care (n=126). Healing was achieved in 44% of patients at 16 weeks with intact fish skin graft compared with 26% for standard of care (P< 0.001, unadjusted), with additional healing at 20 weeks (46% vs. 32%) and 24 weeks (55% vs. 38%). Mean (SD) time to healing was 17.3 (0.69) weeks (95% confidence interval [CI], 15.5 to 18.7) for the intact fish skin graft group and 19.4 (0.66) weeks (95% CI, 18.1 to 20.7) for the standard of care group. In a Cox regression, intact fish skin graft was associated with faster time to healing (hazard ratio, 1.59; 95% CI, 1.07 to 2.36). Primary wound infections were the most common adverse event, occurring in 39 (30.2%) of patients in the intact fish skin graft group and 31 (24.6%) of patients in the standard of care group.

CONCLUSIONS: Among patients with deep diabetic foot ulcers, treatment with intact fish skin graft was superior to standard of care in proportion of wounds healed at 16 weeks and was associated with faster time to healing. (Funded by European Commission Fast Track to Innovation Horizon 2020, and Kerecis Ltd. ClinicalTrials.gov NCT04257370.).

Journal: International wound journal

Diabetic foot ulcers (DFUs) pose a significant risk for infection and limb loss. Advanced wound therapies including human skin allografts have shown promise in resolving these challenging wounds. The primary objective of this randomised, prospective study was to compare the response of 100 subjects with non-healing DFUs of which 50 were treated with a cryopreserved bioactive split thickness skin allograft (BSA) (TheraSkin; Misonix,Inc., Farmingdale, NY) compared with 50 subjects treated with standard of care (SOC, collagen alginate dressing) at 12 weeks. Both groups received standardised care that included glucose monitoring, weekly debridement's as appropriate, and an offloading device. The primary endpoint was proportion of full-thickness wounds healed at 12 weeks, with secondary endpoints including differences in percent area reduction (PAR) at 12 weeks, changes in Semmes-Weinstein monofilament score, VAS pain, and w-QoL. The result illustrated in the intent-to-treat analysis at 12 weeks showed that 76% (38/50) of the BSA-treated DFUs healed compared with 36% (18/50) treated with SOC alone (adjusted P = .00056). Mean PAR at 12 weeks was 77.8% in the BSA group compared with 49.6% in the SOC group (adjusted P = .0019). In conclusion, adding BSA to SOC appeared to significantly improve wound healing with a lower incidence of adverse events related to treatment compared with SOC alone.

© 2022 The Authors. International Wound Journal published by Medicalhelplines.com Inc (3M) and John Wiley & Sons Ltd.

Journal: Journal of comparative effectiveness research

Aim: Determine the effectiveness of hypothermically stored amniotic membrane (HSAM) versus standard of care (SOC) in diabetic foot ulcers (DFUs). Methods: A randomized controlled trial was conducted on 76 DFUs analyzed digitally. Results: Cox wound closure for HSAM (38 wounds) was significantly greater (p = 0.04) at weeks 12 (60 vs 38%), and 16 (63 vs 38%). The probability of wound closure increased by 75% (Hazard Ratio = 1.75; 95% CI: 1.16-2.70). HSAM showed >60% reductions in area (82 vs 58%; p = 0.02) and depth (65 vs 39%; p = 0.04) versus SOC. Conclusion: HSAM increased frequency and probability of wound closure in DFUs versus SOC.

Journal:

Journal: Diabetes/Metabolism Research and Reviews

Diabetic foot ulcer complicated with lower extremity vasculopathy is highly prevalent, slow healing and have a poor prognosis. The final progression leads to amputation, or may even be life-threatening, seriously affecting patients' quality of life. The treatment of lower extremity vasculopathy is the focus of clinical practice and is vital to improving the healing process of diabetic foot ulcers. Recently, a number of clinical trials on diabetic foot ulcers with lower extremity vasculopathy have been reported. A joint group of Chinese Medical Association (CMA) and Chinese Medical Doctor Association (CMDA) expert representatives reviewed and reached a consensus on the guidelines for the clinical diagnosis and treatment of this kind of disease. These guidelines are based on evidence from the literature and cover the pathogenesis of diabetic foot ulcers complicated with lower extremity vasculopathy and the application of new treatment approaches. These guidelines have been put forward to guide practitioners on the best approaches for screening, diagnosing and treating diabetic foot ulcers with lower extremity vasculopathy, with the aim of providing optimal, evidence-based management for medical personnel working with diabetic foot wound repair and treatment.

© 2024 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.

Journal: Wound Repair and Regeneration

Journal: Clinical Infectious Diseases

The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the management and prevention of diabetes-related foot diseases since 1999. The present guideline is an update of the 2019 IWGDF guideline on the diagnosis and management of foot infections in persons with diabetes mellitus. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was used for the development of this guideline. This was structured around identifying clinically relevant questions in the P(A)ICO format, determining patient-important outcomes, systematically reviewing the evidence, assessing the certainty of the evidence, and finally moving from evidence to the recommendation. This guideline was developed for healthcare professionals involved in diabetes-related foot care to inform clinical care around patient-important outcomes. Two systematic reviews from 2019 were updated to inform this guideline, and a total of 149 studies (62 new) meeting inclusion criteria were identified from the updated search and incorporated in this guideline. Updated recommendations are derived from these systematic reviews, and best practice statements made where evidence was not available. Evidence was weighed in light of benefits and harms to arrive at a recommendation. The certainty of the evidence for some recommendations was modified in this update with a more refined application of the GRADE framework centred around patient important outcomes. This is highlighted in the rationale section of this update. A note is also made where the newly identified evidence did not alter the strength or certainty of evidence for previous recommendations. The recommendations presented here continue to cover various aspects of diagnosing soft tissue and bone infections, including the classification scheme for diagnosing infection and its severity. Guidance on how to collect microbiological samples, and how to process them to identify causative pathogens, is also outlined. Finally, we present the approach to treating foot infections in persons with diabetes, including selecting appropriate empiric and definitive antimicrobial therapy for soft tissue and bone infections; when and how to approach surgical treatment; and which adjunctive treatments may or may not affect the infectious outcomes of diabetes-related foot problems. We believe that following these recommendations will help healthcare professionals provide better care for persons with diabetes and foot infections, prevent the number of foot and limb amputations, and reduce the patient and healthcare burden of diabetes-related foot disease.

© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

Journal: Diabetes/Metabolism Research and Reviews

AIMS: Principles of wound management, including debridement, wound bed preparation, and newer technologies involving alternation of wound physiology to facilitate healing, are of utmost importance when attempting to heal a chronic diabetes-related foot ulcer. However, the rising incidence and costs of diabetes-related foot ulcer management necessitate that interventions to enhance wound healing of chronic diabetes-related foot ulcers are supported by high-quality evidence of efficacy and cost effectiveness when used in conjunction with established aspects of gold-standard multidisciplinary care. This is the 2023 International Working Group on the Diabetic Foot (IWGDF) evidence-based guideline on wound healing interventions to promote healing of foot ulcers in persons with diabetes. It serves as an update of the 2019 IWGDF guideline.

MATERIALS AND METHODS: We followed the GRADE approach by devising clinical questions and important outcomes in the Patient-Intervention-Control-Outcome (PICO) format, undertaking a systematic review, developing summary of judgements tables, and writing recommendations and rationale for each question. Each recommendation is based on the evidence found in the systematic review and, using the GRADE summary of judgement items, including desirable and undesirable effects, certainty of evidence, patient values, resources required, cost effectiveness, equity, feasibility, and acceptability, we formulated recommendations that were agreed by the authors and reviewed by independent experts and stakeholders.

RESULTS: From the results of the systematic review and evidence-to-decision making process, we were able to make 29 separate recommendations. We made a number of conditional supportive recommendations for the use of interventions to improve healing of foot ulcers in people with diabetes. These include the use of sucrose octasulfate dressings, the use of negative pressure wound therapies for post-operative wounds, the use of placental-derived products, the use of the autologous leucocyte/platelet/fibrin patch, the use of topical oxygen therapy, and the use of hyperbaric oxygen. Although in all cases it was stressed that these should be used where best standard of care was not able to heal the wound alone and where resources were available for the interventions.

CONCLUSIONS: These wound healing recommendations should support improved outcomes for people with diabetes and ulcers of the foot, and we hope that widescale implementation will follow. However, although the certainty of much of the evidence on which to base the recommendations is improving, it remains poor overall. We encourage not more, but better quality trials including those with a health economic analysis, into this area.

© 2023 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.

Journal: The International Journal of Lower Extremity Wounds

Type 2 diabetes is a significant global health concern. It often causes diabetic foot ulcers (DFUs), which affect millions of people and increase amputation and mortality rates. Despite existing guidelines, the complexity of DFU treatment makes clinical decisions challenging. Large language models such as chat generative pretrained transformer (ChatGPT), which are adept at natural language processing, have emerged as valuable resources in the medical field. However, concerns about the accuracy and reliability of the information they provide remain. We aimed to assess the accuracy of various artificial intelligence (AI) chatbots, including ChatGPT, in providing information on DFUs based on established guidelines. Seven AI chatbots were asked clinical questions (CQs) based on the DFU guidelines. Their responses were analyzed for accuracy in terms of answers to CQs, grade of recommendation, level of evidence, and agreement with the reference, including verification of the authenticity of the references provided by the chatbots. The AI chatbots showed a mean accuracy of 91.2% in answers to CQs, with discrepancies noted in grade of recommendation and level of evidence. Claude-2 outperformed other chatbots in the number of verified references (99.6%), whereas ChatGPT had the lowest rate of reference authenticity (66.3%). This study highlights the potential of AI chatbots as tools for disseminating medical information and demonstrates their high degree of accuracy in answering CQs related to DFUs. However, the variability in the accuracy of these chatbots and problems like AI hallucinations necessitate cautious use and further optimization for medical applications. This study underscores the evolving role of AI in healthcare and the importance of refining these technologies for effective use in clinical decision-making and patient education.

Journal: Circulation

Despite the known higher risk of cardiovascular disease in individuals with type 2 diabetes, the pathophysiology and optimal management of diabetic foot ulcers (DFUs), a leading complication associated with diabetes, is complex and continues to evolve. Complications of type 2 diabetes, such as DFUs, are a major cause of morbidity and mortality and the leading cause of major lower extremity amputation in the United States. There has recently been a strong focus on the prevention and early treatment of DFUs, leading to the development of multidisciplinary diabetic wound and amputation prevention clinics across the country. Mounting evidence has shown that, despite these efforts, amputations associated with DFUs continue to increase. Furthermore, due to increasing patient complexity of management secondary to comorbid conditions, such as cardiovascular disease, the management of peripheral artery disease associated with DFUs has become increasingly difficult, and care delivery is often episodic and fragmented. Although structured, process-specific approaches exist at individual institutions for the management of DFUs in the cardiovascular patient population, there is insufficient awareness of these principles in the general medicine communities. Furthermore, there is growing interest in better understanding the mechanistic underpinnings of DFUs to better define personalized medicine to improve outcomes. The goals of this scientific statement are to provide salient background information on the complex pathogenesis and current management of DFUs in cardiovascular patients, to guide therapeutic and preventive strategies and future research directions, and to inform public policy makers on health disparities and other barriers to improving and advancing care in this expanding patient population.

Journal: Diabetes/Metabolism Research and Reviews

AIMS: Offloading mechanical tissue stress is arguably the most important of multiple interventions needed to heal diabetes-related foot ulcers. This is the 2023 International Working Group on the Diabetic Foot (IWGDF) evidence-based guideline on offloading interventions to promote healing of foot ulcers in persons with diabetes. It serves as an update of the 2019 IWGDF guideline.

MATERIALS AND METHODS: We followed the GRADE approach by devising clinical questions and important outcomes in the PICO (Patient-Intervention-Control-Outcome) format, undertaking a systematic review and meta-analyses, developing summary of judgement tables and writing recommendations and rationales for each question. Each recommendation is based on the evidence found in the systematic review, expert opinion where evidence was not available, and a careful weighing of GRADE summary of judgement items including desirable and undesirable effects, certainty of evidence, patient values, resources required, cost effectiveness, equity, feasibility, and acceptability.

RESULTS: For healing a neuropathic plantar forefoot or midfoot ulcer in a person with diabetes, use a non-removable knee-high offloading device as the first-choice offloading intervention. If contraindications or patient intolerance to non-removable offloading exist, consider using a removable knee-high or ankle-high offloading device as the second-choice offloading intervention. If no offloading devices are available, consider using appropriately fitting footwear combined with felted foam as the third-choice offloading intervention. If such a non-surgical offloading treatment fails to heal a plantar forefoot ulcer, consider an Achilles tendon lengthening, metatarsal head resection, joint arthroplasty, or metatarsal osteotomy. For healing a neuropathic plantar or apex lesser digit ulcer secondary to flexibile toe deformity, use digital flexor tendon tenotomy. For healing rearfoot, non-plantar or ulcers complicated with infection or ischaemia, further recommendations have been outlined. All recommendations have been summarised in an offloading clinical pathway to help facilitate the implementation of this guideline into clinical practice.

CONCLUSION: These offloading guideline recommendations should help healthcare professionals provide the best care and outcomes for persons with diabetes-related foot ulcers and reduce the person's risk of infection, hospitalisation and amputation.

© 2023 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.

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Journal: Current diabetes reviews

BACKGROUND: Diabetic Foot is a severe chronic complication of diabetes and an important factor in the morbidity of diabetic people, resulting in high health costs and increased risk of death.

OBJECTIVE: to analyze the incidence, prevalence, and risk factors associated with diabetic foot in people with type 2 Diabetes Mellitus.

METHOD: Systematic literature review. Searches in MedLine via PubMed, LILACS, Web of Science, Scopus CINAHL, and Cochrane Library databases were performed. Inclusion of 52 studies. The R program, Metan packages, was used to calculate the meta-analysis. Given the heterogeneity of studies, the random effect was used to calculate the meta-analysis of risk factors.

RESULTS: The meta-analysis showed that the prevalence of diabetic foot was 14% in a hospital setting and 5% in a community setting. The overall prevalence and incidence were 9% and 4%, respectively. Significant risk factors included time of DM (odds ratio [OR] =1.46, confidence interval [CI], 0.36-2.57, P = 0.009), smoking (OR = 1.46, CI, 1.16 -1.85, P< .001), glycated hemoglobin (OR = 0.96, CI, 0.50; 1.42, P< .001), peripheral arterial disease (OR = 3.38, CI, 2.07; 5.53, P < .001) and peripheral neuropathy (OR = 5.88, CI, 2.39-14.45, P< .001).

CONCLUSION: Multidisciplinary monitoring, educational strategies, periodic foot examination for alterations, and early identification of risk factors are essential to prevent ulceration and reduce the disease burden.

Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.

Journal: Diabetes/Metabolism Research and Reviews

BACKGROUND: Classification and scoring systems can help both clinical management and audit the outcomes of routine care.

AIM: This study aimed to assess published systems used to characterise ulcers in people with diabetes to determine which should be recommended to (a) aid communication between health professionals, (b) predict clinical outcome of individual ulcers, (c) characterise people with infection and/or peripheral arterial disease, and (d) audit to compare outcomes in different populations. This systematic review is part of the process of developing the 2023 guidelines to classify foot ulcers from the International Working Group on Diabetic Foot.

METHODS: We searched PubMed, Scopus and Web of Science for articles published up to December 2021 which evaluated the association, accuracy or reliability of systems used to classify ulcers in people with diabetes. Published classifications had to have been validated in populations of >80% of people with diabetes and a foot ulcer.

RESULTS: We found 28 systems addressed in 149 studies. Overall, the certainty of the evidence for each classification was low or very low, with 19 (68%) of the classifications being assessed by ≤ 3 studies. The most frequently validated system was the one from Meggitt-Wagner, but the articles validating this system focused mainly on the association between the different grades and amputation. Clinical outcomes were not standardized but included ulcer-free survival, ulcer healing, hospitalisation, limb amputation, mortality, and cost.

CONCLUSION: Despite the limitations, this systematic review provided sufficient evidence to support recommendations on the use of six particular systems in specific clinical scenarios.

© 2023 John Wiley & Sons Ltd.

Journal: Diabetes/Metabolism Research and Reviews

BACKGROUND: This publication represents a scheduled update of the 2019 guidelines of the International Working Group of the Diabetic Foot (IWGDF) addressing the use of systems to classify foot ulcers in people with diabetes in routine clinical practice. The guidelines are based on a systematic review of the available literature that identified 28 classifications addressed in 149 articles and, subsequently, expert opinion using the GRADE methodology.

METHODS: First, we have developed a list of classification systems considered as being potentially adequate for use in a clinical setting, through the summary of judgements for diagnostic tests, focussing on the usability, accuracy and reliability of each system to predict ulcer-related complications as well as use of resources. Second, we have determined, following group debate and consensus, which of them should be used in specific clinical scenarios. Following this process, in a person with diabetes and a foot ulcer we recommend: (a) for communication among healthcare professionals: to use the SINBAD (Site, Ischaemia, Bacterial infection, Area and Depth) system (first option) or consider using WIfI (Wound, Ischaemia, foot Infection) system (alternative option, when the required equipment and level of expertise is available and it is considered feasible) and in each case the individual variables that compose the systems should be described rather than a total score; (b) for predicting the outcome of an ulcer in a specific individual: no existing system could be recommended; (c) for characterising a person with an infected ulcer: the use of the IDSA/IWGDF classification (first option) or consider using the WIfI system (alternative option, when the required equipment and level of expertise is available and it is considered as feasible); (d) for characterising a person with peripheral artery disease: consider using the WIfI system as a means to stratify healing likelihood and amputation risk; (e) for the audit of outcome(s) of populations: the use of the SINBAD score.

CONCLUSIONS: For all recommendations made using GRADE, the certainty of evidence was judged, at best, as being low. Nevertheless, based on the rational application of current data this approach allowed the proposal of recommendations, which are likely to have clinical utility.

© 2023 John Wiley & Sons Ltd.

Journal: Diabetes/Metabolism Research and Reviews

AIMS: This is the 2023 International Working Group on the Diabetic Foot guideline on the prevention of foot ulcers in persons with diabetes, which updates the 2019 guideline. This guideline is targeted at clinicians and other healthcare professionals.

MATERIALS AND METHODS: We followed the Grading of Recommendations, Assessment, Development and Evaluations methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature including, where appropriate, meta-analyses, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where (sufficient) evidence was not available, and a weighing of the desirable and undesirable effects of an intervention, as well as patient preferences, costs, equity, feasibility and applicability.

RESULTS: We recommend screening a person with diabetes at very low risk of foot ulceration annually for the loss of protective sensation and peripheral artery disease, and screening persons at higher risk at higher frequencies for additional risk factors. For preventing a foot ulcer, educate persons at-risk about appropriate foot self-care, educate not to walk without suitable foot protection, and treat any pre-ulcerative lesion on the foot. Educate moderate-to-high risk people with diabetes to wear properly fitting, accommodative, therapeutic footwear, and consider coaching them to monitor foot skin temperature. Prescribe therapeutic footwear that has a demonstrated plantar pressure relieving effect during walking, to help prevent plantar foot ulcer recurrence. Consider advising people at low-to-moderate risk to undertake a, preferably supervised, foot-ankle exercise programme to reduce ulcer risk factors, and consider communicating that a total increase in weight-bearing activity of 1000 steps/day is likely safe with regards to risk of ulceration. In people with non-rigid hammertoe with pre-ulcerative lesion, consider flexor tendon tenotomy. We suggest not to use a nerve decompression procedure to help prevent foot ulcers. Provide integrated foot care for moderate-to-high-risk people with diabetes to help prevent (recurrence of) ulceration.

CONCLUSIONS: These recommendations should help healthcare professionals to provide better care for persons with diabetes at risk of foot ulceration, to increase the number of ulcer-free days and reduce the patient and healthcare burden of diabetes-related foot disease.

© 2023 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.

Journal: Diabetic Medicine

INTRODUCTION: Topical oxygen therapy (TOT) has been suggested as a treatment for diabetes- related foot ulcer (DFU) but no prior meta-analyses of randomised clinical trials (RCT) have been reported. This systematic review and meta-analysis examined the randomised evidence for the benefit of TOT in healing DFU.

METHODS: Publicly available databases were searched for RCTs investigating the effect of TOT on wound healing in participants with a DFU. The primary outcome was ulcer healing defined as full epithelialisation. Meta-analyses were performed using random effect models and reported as risk ratios (RR) and 95% confidence intervals (CI). Study quality and publication bias were assessed using a modified version of the Cochrane Collaboration's tool and funnel plots respectively.

RESULTS: Six RCTs involving 530 participants with a DFU testing TOT were included. Meta-analysis suggested that TOT significantly increased the likelihood of ulcer healing compared to controls (Risk ratio (RR) 1.94; 95% CI 1.19, 3.17; I2 =57%; NNT=5.33) and findings were robust in sensitivity analyses. Risk of bias was high, moderate and low in two, one and three studies respectively. Analysis of the three trials judged to be at low risk of bias suggested that TOT increased the likelihood of ulcer healing compared to controls (RR 2.37; 95% CI 1.52, 3.68; I2 =0%). Funnel plots suggested the possibility of publication bias. Data on amputation were too limited for meta-analysis.

CONCLUSION: This meta-analysis suggests that TOT improves the likelihood of DFU healing, however, its effect on amputation and cost-effectiveness are unclear.

This article is protected by copyright. All rights reserved.

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Journal: Pharmaceuticals (Basel, Switzerland)

Chronic wounds often occur in patients with diabetes mellitus due to the impairment of wound healing. This has negative consequences for both the patient and the medical system and considering the growing prevalence of diabetes, it will be a significant medical, social, and economic burden in the near future. Hence, the need for therapeutic alternatives to the current available treatments that, although various, do not guarantee a rapid and definite reparative process, appears necessary. We here analyzed current treatments for wound healing, but mainly focused the attention on few classes of drugs that are already in the market with different indications, but that have shown in preclinical and few clinical trials the potentiality to be used in the treatment of impaired wound healing. In particular, repurposing of the antiglycemic agents dipeptidylpeptidase 4 (DPP4) inhibitors and metformin, but also, statins and phenyotin have been analyzed. All show encouraging results in the treatment of chronic wounds, but additional, well designed studies are needed to allow these drugs access to the clinics in the therapy of impaired wound healing.

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Journal: Journal of Wound, Ostomy, and Continence Nursing

This article provides an executive summary of the Wound, Ostomy, and Continence Nurses Society's (WOCN) "2021 Guideline for Management of Patients With Lower-Extremity wounds Due to Diabetes Mellitus and/or Neuropathic Disease." This executive summary presents an overview of the systematic process used to update and develop the guideline and recommendations from the guideline for screening and diagnosis, assessment, and management and education of patients with lower-extremity wounds due to diabetes mellitus and/or neuropathic disease. In addition, the executive summary provides suggestions for implementing recommendations from the guideline. The guideline is a resource for WOC nurse specialists and other nurses and health care professionals who work with adults who have/or are at risk for lower-extremity wounds due to diabetes mellitus/neuropathic disease. The complete guideline includes the evidence and references supporting the recommendations, and it is available in print and electronically from the Wound, Ostomy, and Continence Nurses Society, 1120 Rt 73, Suite 200, Mount Laurel, New Jersey, 08054; Web site: www.wocn.org.

Copyright © 2022 by the Wound, Ostomy and Continence Nurses Society.

Journal: Journal of clinical medicine

This study aimed to validate the association between the grades of severity of diabetic foot ulcers (DFUs) identified by the fast-tack model and specific outcomes. Three hundred and sixty-seven patients with new DFUs who were referred to a tertiary level diabetic foot service serving Rome, Italy, were included. The fast-track model identifies three levels of DFUs' severity: uncomplicated DFUs, including superficial wounds, not-infected wounds, and not-ischemic wounds; complicated DFUs, including ischemic wounds, infected wounds, and deep ulcers involving the muscles, tendons, or bones, and any kind of ulcers in patients on dialysis and/or with heart failure; and severely complicated DFUs, including abscesses, wet gangrene, necrotizing fasciitis, fever, or clinical signs of sepsis. Healing, minor and major amputation, hospitalization, and survival after 24 weeks of follow-up were considered. Among the included patients, 35 (9.6%) had uncomplicated DFUs, 210 (57.2%) had complicated DFUs, and 122 (33.2%) had severely complicated DFUs. The outcomes for patients with uncomplicated, complicated, and severely complicated DFUs were as follows, respectively: healing, 97.1%, 86.2%, and 69.8%; minor amputation, 2.9%, 20%, and 66.4%; major amputation, 0%, 2.9%, and 16.4%; hospitalization, 14.3%, 55.7%, and 89.3%; survival, 100%, 96.7%, and 89.3%. DFU severity was an independent predictor of healing, amputation, hospitalization, and survival. The current study shows an association between the grade of severity of DFUs identified by the fast-track model and the considered outcomes. The fast-track model may be a useful tool for assessing the severity and prognosis of DFUs.

Journal: Journal of clinical medicine

Autologous and recombinant biologic substances have been generated as a result of the research into the cellular features of the healing process. Orthobiologics are increasingly being used in sports medicine and musculoskeletal surgery. Nevertheless, clinical data are limited; consequently, further studies are required, particularly in foot and ankle pathologies. This review aims to provide evidence of the most recent literature results and ignite the interest of orthopedic specialists eager for an update about the most current discussion on platelet-rich plasma (PRP) clinical applications in the foot and ankle fields. Previous studies have shown that platelet-rich plasma can be beneficial in treating various conditions, such as chronic foot ulcers, osteoarthritis, Achilles tendinopathy, etc. Despite the positive effects of PRP on various musculoskeletal conditions, more prospective studies are needed to confirm its effectiveness at treating ankle and foot pathologies. In addition to clinical trials, other factors, such as the quality of the research and the procedures involved, must be considered before they can be used in patients. More long-term evaluations are needed to support or oppose its application in treating foot and ankle disorders. We present the most extensive review of PRP's clinical applications in the foot and ankle field.

Journal: Sensors (Basel, Switzerland)

Adherence to prescribed footwear is essential to prevent diabetes-related foot ulcers. The aim was to compare different measures of adherence and wearing time of prescribed footwear with a reference adherence measure, among people with diabetes at high risk of foot ulceration. We followed 53 participants for 7 consecutive days. A temperature sensor measured wearing time of prescribed footwear and a triaxial accelerometer assessed weight-bearing activities. Subjective wearing time was self-reported. Reference adherence measure was proportion of weight-bearing time prescribed footwear was worn. We calculated Spearman's correlation coefficients, kappa coefficients, and areas under the curve (AUC) for the association between the reference measure and other measures of adherence and wearing time. Proportion of daily steps with prescribed footwear worn had a very strong association (r = 0.96, Κ = 0.93; AUC: 0.96-1.00), objective wearing time had a strong association (r = 0.91, Κ = 0.85, AUC: 0.89-0.99), and subjective wearing time had a weak association (r = 0.42, Κ = 0.38, AUC: 0.67-0.81) with the reference measure. Objectively measured proportion of daily steps with prescribed footwear is a valid measure of footwear adherence. Objective wearing time is reasonably valid, and may be used in clinical practice and for long-term measurements. Subjective wearing time is not recommended to be used.

Journal: Seminars in musculoskeletal radiology

Management of the diabetic foot is complex and challenging, requiring a multidisciplinary approach. Imaging plays an important role in the decision-making process regarding surgery. This article discusses the presurgical perspective and postsurgical evaluation of the diabetic foot.

Thieme. All rights reserved.

Journal: Journal of Wound Care

OBJECTIVE: The aim of this systematic review was to determine the impact of topical oxygen therapy (TOT) on diabetic foot ulcer (DFU) healing.

METHOD: Using systematic review methodology, we considered randomised controlled trials (RCTs), controlled trials, pilot studies and observational studies. The search was conducted in January 2019, using PubMed, CINAHL, Ovid, Cochrane, Web of Science and EMBASE databases. Data analysis was undertaken using RevMan and a narrative synthesis. The article titles were assessed by two authors independently, and the abstracts (when available) of the studies identified by the search strategy were screened for their eligibility, according to the inclusion and exclusion criteria. The full-text version of potentially relevant studies was obtained and two authors independently screened this against the inclusion criteria. Data were extracted using a predesigned extraction tool and all included studies were quality appraised using the Evidence-Based Librarianship checklist.

RESULTS: The search returned 565 records of which eight met the inclusion criteria. Of the included studies, three were set in single centre outpatient wound clinics, two studies were set in an outpatient wound care research clinic and three studies were multisite. Meta-analysis of four studies was undertaken. DFUs are >2 times more likely to heal with TOT than with standard care alone. The odds ratio (OR)=2.49 (95% confidence interval (CI): 1.59-3.90, p=0.00001). The remaining four studies also showed that using TOT increased healing rates. An included study reported that time to 50% DFU closure was significantly shorter in participants who received the TOT, mean 18.4 days versus 28.9 days in the sham therapy group (p=0.001). However, the validity of 65.5% of the eight studies was assessed as low.

CONCLUSION: The findings suggest that TOT enhances healing for patients with hard-to-heal DFUs when used with standard care. The results from the trials reviewed also indicate a benefit for patients over standard care alone. However, the sample sizes in the studies were generally small, thus, more RCTs are warranted to further validate these findings.

DECLARATION OF INTEREST: The authors have no conflicts of interest to declare.

Journal: Annals of palliative medicine

BACKGROUND: Negative pressure wound therapy (NPWT) is one of the new modality for the treatment of diabetic foot ulcers. In this article we will investigate the efficacy and safety of it by literature search and meta-analysis.

METHODS: The databases of PubMed, Embase, Ovid, and Cochrane library were selected as search platforms. Randomized controlled trials (RCTs) published after 2010 were searched with the keyword "vacuum-assisted closure therapy" OR "negative pressure wound therapy" OR "diabetic foot". The Cochrane Review Handbook was used to assess the bias of the literatures. The software RevMan 5.4 was used for analysis to obtain a forest plot and funnel plot.

RESULTS: In this study, 363 articles were initially screened, and 9 literatures were finally included, involving a total of 943 patients. Combined analysis using the fixed effects model showed that the healing rate of the NPWT group was significantly lower than the standard group [odds ratio (OR) =3.60, 95% confidence interval (CI): 2.38 to 5.45, P< 0.001]. The granulation tissue formation time of the NPWT group was significantly less than the standard group [mean difference (MD) =-8.95, 95% CI: -10.26 to -7.64, P< 0.001]. The rate of adverse events of both groups showed no significant difference (OR =0.49, 95% CI: 0.10 to 2.42, P=0.38). The amputation rate of both groups showed no statistically significant (OR =0.33, 95% CI: 0.09 to 1.26, P=0.10) too.

DISCUSSION: Negative pressure wound therapy can effectively accelerate wound healing, it is equally safe with general routine treatment. However, the negative pressure value should be appropriately maintained and adjusted to avoid bleeding tendency of the wound when applying this new modality.

Journal: Frontiers in endocrinology

Background: Diabetic foot ulcers are a major complication of diabetes mellitus (DM), when heparin and heparin related substances may be potentially used as an adjuvant treatment. We aimed to evaluate the efficacy and safety of heparin and heparin related substances for the treatment of diabetic foot ulcers.

Methods: We searched up to March 2021 in the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; EBSCO CINAHL; VIP Chinese Science and Technique Journals Database; China National Knowledge Infrastructure (CNKI) Database and Wan Fang Database investigating heparin or heparin-related substances in patients with diabetic foot ulcers. The primary outcomes included proportion of ulcers completely healed and time to complete ulcer healing. We assessed each included study with the Cochrane 'Risk of bias' tool and used the GRADE approach to assess the overall quality of the evidence.

Results: We included nine randomized studies involving 620 participants in the meta-analysis, involving two different heparin and heparin-related substances, low molecular weight heparin (LMWH) and hyaluronic acid. Our study did not show the benefits from LMWH on increasing chance of the ulcer healing (RR: 1.26; 95% CI: 0.78 to 2.04; P=0.35; very low) or shortening the time to complete ulcer healing (SMD: 0.13 d; 95% CI: -0.29 to 0.56; P=0.54; very low). Hyaluronic acid may improve the complete ulcer healing (RR: 1.57; 95% CI: 1.29 to 1.91; P˂0.00001; very low) and shorten the time to complete ulcer healing (SMD -0.84, 95% CI -1.15 to -0.53; P< 0.00001; low). Hyaluronic acid and LMWH were generally well tolerated for treating diabetic foot ulcers in this review.

Conclusion: Hyaluronic acid may improve diabetic foot ulcer with very low quality evidence but not LMWH. However, the benefits and harms need further validation in larger trials with different population.

Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/], identifier [PROSPERO, CRD42021269212].

Copyright © 2022 Su, Xu, Li, Zheng, Wu, Zhang, Zhou, Du and Zhao.

Journal: British journal of community nursing

This article explores how nurses can use evidence-based practice to appraise the rationale and evidence for specific nursing procedures or practices. A literature review of published evidence on honey dressings for diabetic foot ulcers was conducted by a novice researcher (lead author) under the supervision of a lecturer (second author). A methodology was followed to construct an answerable research question and to guide the search and retrieval of evidence. The strengths and limitations of a selected study were appraised, and its implications for practice considered. This article highlights an area of practice that warrants further attention and demonstrates the use of evidence-based practice to consider the quality and utility of clinical research.

Journal: Advances in wound care

Background: This study sought to examine the real-world impact of multimodality cyclical-pressure topical wound oxygen therapy (TWO2) on hospitalizations and amputations in patients with diabetic foot ulcer (DFU) compared with patients without TWO2. Methods: We conducted a retrospective review of deidentified patient medical records at 2 U.S. Veterans Affairs hospitals between January 2012 and January 2020. DFU patients were assigned to TWO2 or NO TWO2 cohorts based on their treatment records. Patients received appropriate standard of care and may have received other advanced wound treatments, including skin substitutes, negative pressure wound therapy, and growth factors. Primary study outcomes were patients requiring hospitalization and/or amputation within 360 days of initial wound documentation. Findings: Among unmatched cohorts of 202 patients with DFU (91 TWO2, 111 NO TWO2), 6.6% and 12.1% of TWO2 patients had hospitalizations and amputations, respectively, compared with 54.1% and 41.4% of NO TWO2 patients within 360 days (p <  0.0001, p <  0.0001), representing 88% and 71% reductions. Among propensity score-matched cohorts of 140 DFU patients (70 TWO2, 70 NO TWO2), compared with NO TWO2, 82% fewer TWO2 patients were hospitalized (7.1% vs. 40.0%, p <  0.0001) and 73% fewer TWO2 patients had amputations (8.6% vs. 31.4%, p = 0.0007). Logistic regression among matched cohorts demonstrated nearly ninefold and fivefold higher risk of hospitalization and amputation, respectively, for NO TWO2 versus TWO2. Interpretation: This retrospective cohort study demonstrates that treating patients with DFU with TWO2 is associated with significant reductions in hospitalizations and amputations in the real-world setting.

Journal: Advances in skin & wound care

OBJECTIVE: To discuss human amnion chorion (placental) membrane allograft (HACMA) use for the treatment of chronic diabetic foot ulcers (DFUs) and to evaluate the effectiveness, cost, and product waste of this therapy.

DATA SOURCES: PubMed, Cochrane, and OVID databases.

STUDY SELECTION: Twenty-four articles pertaining to HACMA and DFUs published from 2016 to 2020 were selected.

DATA EXTRACTION: The data collected included type of wound care product, study design, study size, baseline size of DFU, cost, product wastage, number of applications, and wound healing outcomes.

DATA SYNTHESIS: Human amnion chorion membrane allografts in the treatment of chronic DFUs have led to a reduction in healing time and increased the overall percentage of healing, making them more effective in treating DFUs compared with standard of care. These products are offered in multiple sizes with various shelf lives and methods of storage, making them accessible, easy to use, less wasteful, and lower in cost compared with other commercially available products. Promising evidence demonstrates that HACMAs are beneficial in treating complex, high-grade DFUs with exposed tendon or bone.

CONCLUSIONS: Human amnion chorion membrane allografts are effective in treating chronic DFUs with a greater percentage of complete wound closure and a reduction in healing time versus standard of care.

Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.

Journal: Wound Repair and Regeneration

A prospective, single arm feasibility study was conducted to evaluate healing outcomes of DFUs treated with autologous skin cell suspension (ASCS) in combination with standard therapy. Wounds up to 100 cm2 in size that failed to heal with conventional therapy were included and wound healing, pain, exudate scores, Quality of Life, satisfaction scores, and safety outcomes were evaluated over a period of 26 weeks. Sixteen subjects were enrolled having a mean DFU duration of 60.4 weeks. All ulcers in this study had a positive healing trajectory, with a mean reepithelialization of 84.9% and 12.2 cm2 reduction in ulcer area. For ulcers that did not acquire a soft tissue infection post-treatment, all either healed or achieved ≥95% reepithelialization including some with exposed tendon. Improvements were observed in all aspects of the health-related Quality of Life questionnaire and subjects and clinicians were highly satisfied across all postoperative visits. This preliminary study suggests ASCS is a well-tolerated and promising therapy for the treatment of DFUs as all ulcers evaluated experienced positive healing results regardless of size, depth, and wound duration. Future studies are warranted to investigate ASCS compared to standard of care for all diabetic foot ulcers, inclusive of the evaluation of treatment algorithms and combination products.

© 2020 The Authors. Wound Repair and Regeneration published by Wiley Periodicals LLC on behalf of The Wound Healing Society.

Journal: The International Journal of Lower Extremity Wounds

Diabetic foot ulcer is one of the most devastating complications of uncontrolled diabetes. Although there have been advances in the management of diabetic foot ulcers, still diabetic foot ulcers are a major cause of many amputations in diabetic patients. Teucrium polium (T. polium) is widely used by folk medicine practitioners in Iran for the treatment of diabetic ulcers.The present study was designed to evaluate the safety and efficacy of topical T. polium ointment besides the standard treatment in diabetic foot ulcers.A total of 70 diabetic patients with foot ulcers grade 1 or 2 according to Wagner's scale were enrolled in this study. Patients were randomly divided into two groups. Patients in both groups received standard treatment for diabetic foot ulcers. In addition, group 1 received topical T. polium ointment, and group 2 received topical placebo ointment for 4 weeks. The T. polium and placebo ointments were rubbed twice daily two hours before the conventional dressing. The ulcer size, healing time, and laboratory tests were measured in both groups at baseline and end of the study after 4 weeks.Twenty-nine patients remained in the T. polium group and 26 in the placebo group until the end of the study. The mean surface area of ulcers was 3.52 ± 1.47 and 3.21 ± 1.67 cm2 in T. polium group and placebo group respectively at baseline which decrease to .717 ± .19 and 1.63 ± .72 cm2 respectively at the endpoint. The mean ulcer surface area was significantly lower in T. polium compared with the placebo group (p <  .0001) at end of the study. Also, the number of patients that completely recovered in the T. polium group was significantly higher than the placebo group (p <  .001) at the end of the study.The addition of topical T. polium ointment to standard treatment significantly improves the healing time of diabetic non-infected foot ulcers.

Journal: Journal of diabetes science and technology

BACKGROUND: Diabetic foot ulcers (DFUs) are a leading cause of disability and morbidity. There is an unmet need for a simple, practical, home method to detect DFUs early and remotely monitor their healing.

METHOD: We developed a simple, inexpensive, smartphone-based, "Foot Selfie" system that enables patients to photograph the plantar surface of their feet without assistance and transmit images to a remote server. In a pilot study, patients from a limb-salvage clinic were asked to image their feet daily for six months and to evaluate the system by questionnaire at five time points. Transmitted results were reviewed weekly.

RESULTS: Fifteen patients (10 male) used the system after approximately 5 minutes of instruction. Participants uploaded images on a median of 76% of eligible study days. The system captured and transmitted diagnostic quality images of the entire plantar surface of both feet, permitting clinical-management decisions on a remote basis. We monitored 12 active wounds and 39 pre-ulcerative lesions (five wounds and 13 pre-ulcerative lesions at study outset); we observed healing of seven wounds and reversal of 20 pre-ulcerative lesions. Participants rated the system as useful, empowering, and preferable to their previous methods of foot screening.

CONCLUSIONS: With minimal training, patients transmitted diagnostic-quality images from home on most days, allowing clinicians to review serial images. This system permits inexpensive home foot screening and monitoring of DFUs. Further studies are needed to determine whether it can reduce morbidity of DFUs and/or the associated cost of care. Artificial intelligence integration could improve scalability.

Journal: Acta Biomaterialia

Diabetic foot ulcers (DFUs) are a devastating ailment for many diabetic patients with increasing prevalence and morbidity. The complex pathophysiology of DFU wound environments has made finding effective treatments difficult. Standard wound care treatments have limited efficacy in healing these types of chronic wounds. Topical biomaterial gels have been developed to implement novel treatment approaches to improve therapeutic effects and are advantageous due to their ease of application, tunability, and ability to improve therapeutic release characteristics. Here, we provide an updated, comprehensive review of novel topical biomaterial gels developed for treating chronic DFUs. This review will examine preclinical data for topical gel treatments in diabetic animal models and clinical applications, focusing on gels with protein/peptides, drug, cellular, herbal/antioxidant, and nano/microparticle approaches. STATEMENT OF SIGNIFICANCE: By 2050, 1 in 3 Americans will develop diabetes, and up to 34% of diabetic patients will develop a diabetic foot ulcer (DFU) in their lifetime. Current treatments for DFUs include debridement, infection control, maintaining a moist wound environment, and pressure offloading. Despite these interventions, a large number of DFUs fail to heal and are associated with a cost that exceeds $31 billion annually. Topical biomaterials have been developed to help target specific impairments associated with DFU with the goal to improve healing. A summary of these approaches is needed to help better understand the current state of the research. This review summarizes recent research and advances in topical biomaterials treatments for DFUs.

Copyright © 2021 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

Journal: International Immunopharmacology

AIM: The effectiveness of nanofibers containing human placenta-derived mesenchymal stem cells (hPDMSCs) plus platelet-rich plasma (PRP) for healing of diabetic foot ulcers (DFUs) was investigated.

METHODS: hPDMSCs were isolated from human donor placentas, and cultured in electrospun gelatin nanofibrous scaffolds (GNS). Twenty-eight patients with DFUs were randomized into three groups in a 12-week trial: (A) Treated with hPDMSCs; (B) Treated with hPDMSCs after coating the ulcer with PRP gel; (C) Control group received standard wound care. Wound area and pain freewalkingdistance were measured every 2 weeks.

RESULTS: Flow cytometry showed the expression of mesenchymal markers. SEM images and DAPI staining indicated significantly higher levels of hPDMSC proliferation on GNS after 3 and 7 days of culture. The MTS assay showed a significant increase in proliferation on GNS, compared to controls. Wound size reduction was 66% in group A, 71% in group B, and 36% in control group C. A significant difference in wound closure and pain-free walking distance was observed between groups A and B, compared to control group C (p <  0.05), but no difference between groups A and B. Biopsy of the implanted tissue showed the development of new capillary formation in groups A and B.

CONCLUSION: Implantation of hPDMSCs in GNS accelerated wound healing and improved clinical parameters in DFU patients.

Copyright © 2021. Published by Elsevier B.V.

Journal: Open forum infectious diseases

Background: Diabetes is the leading cause of lower extremity nontraumatic amputation globally, and diabetic foot osteomyelitis (DFO) is usually the terminal event before limb loss. Although guidelines recommend percutaneous bone biopsy (PBB) for microbiological diagnosis of DFO in several common scenarios, it is unclear how frequently PBBs yield positive cultures and whether they cause harm or improve outcomes.

Methods: We searched the PubMed, EMBASE, and Cochrane Trials databases for articles in any language published up to December 31, 2019, reporting the frequency of culture-positive PBBs. We calculated the pooled proportion of culture-positive PBBs using a random-effects meta-analysis model and reported on PBB-related adverse events, DFO outcomes, and antibiotic adjustment based on PBB culture results where available.

Results: Among 861 articles, 11 studies met inclusion criteria and included 780 patients with 837 PBBs. Mean age ranged between 56.6 and 71.0 years old. The proportion of males ranged from 62% to 86%. All studies were longitudinal observational cohorts, and 10 were from Europe. The range of culture-positive PBBs was 56%-99%, and the pooled proportion of PBBs with a positive culture was 84% (95% confidence interval, 73%-91%). There was heterogeneity between studies and no consistency in definitions used to define adverse events. Impact of PBB on DFO outcomes or antibiotic management were seldom reported.

Conclusions: This meta-analysis suggests PBBs have a high yield of culture-positive results. However, this is an understudied topic, especially in low- and middle-income countries, and the current literature provides very limited data regarding procedure safety and impact on clinical outcomes or antibiotic management.

© The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.