Variation in Systemic Antibiotic Treatment for Diabetic Foot Osteomyelitis in England and Wales: A Multi-Centre Case Review.

Background: Diabetic foot osteomyelitis (DFO) is a major complication and can lead to significant morbidity and mortality. Systemic antibiotic therapy is often initiated first line to achieve quiescence of infection. To perform a multi-centre case review of systemic antibiotic intervention to treat adults with DFO in England and Wales and compare with national guidelines 'Diabetic foot problems: prevention and management'. Methods: Eight centres from England and Wales retrospectively collated data from a minimum of five adults (aged ≥ 18 years) from electronic case records. All patients were treated with systemic antibiotics following a new diagnosis of DFO (1 June 2021-31 December 2021). Results: 40 patients (35 males and 5 females) were included; the mean age was 62.3 years (standard deviation (SD) 13.0). Patients commenced systemic oral 14 (35%) or intravenous 26 (65%) antibiotic therapy following a new diagnosis of DFO. Twenty-seven (67.5%) patients were medically or surgically managed in the 12-week period with clinical quiescence of infection. Twenty-one patients (52.5%) had no recurrence of DFO infection within 12 weeks; seventeen (42.5%) of these patients had clinical quiescence of infection with systemic antibiotics alone without surgical intervention and nine (22.5%) of these cases had no recurrence of DFO. There were no cases of major amputation or death. All centres showed significant in-centre variability in systemic antibiotic management; variability was reported in the clinical and quantity indicators specifically to antibiotic selection, single versus dual therapy, mode of delivery and duration of treatment. Conclusions: This case review identifies there is existing variation when treating adults with systemic antibiotics for DFO. Further national guidance is required to standardise service delivery and care to improve patient outcomes.

Causes, prevention, and management of diabetes-related foot ulcers.

In this Review, we aim to complement the 2023 update of the guidelines of the International Working Group on the Diabetic Foot. We highlight the complexity of the pathological processes that underlie diabetes-related foot ulceration (DFU) and draw attention to the potential implications for clinical management and outcome. Variation observed in the incidence and outcome of DFUs in different communities might result from differences in study populations and the accessibility of care. Comparing differences in incidence, management, and outcome of DFUs in different communities is an essential component of the quality of disease care. Additionally, these comparisons can also highlight the relationship between DFU incidence, management, and outcome and the structure of local clinical services and the availability of staff with the necessary skills. The clinical outcome is, however, also dependent on the availability of multidisciplinary care and the ability of people with DFUs to gain access to that care.

The unique multidisciplinarity of diabetes-related foot disease.

Few diseases globally require treatment from so many different disciplines as diabetes-related foot disease. At least 25 different professionals may be involved: casting technicians, dermatologists, diabetes (educator) nurses, diabetologists, dieticians, endocrinologists, general practitioners, human movement scientists, infectious diseases experts, microbiologists, nuclear medicine physicians, orthopaedic surgeons, orthotists, pedorthists, physical therapists, plastic surgeons, podiatric surgeons, podiatrists, prosthetists, psychologists, radiologists, social workers, tissue viability physicians, vascular surgeons, and wound care nurses. A shared vocabulary and shared treatment goals and recommendations are then essential. The International Working Group on the Diabetic Foot (IWGDF) has produced guidelines and supporting documents to stimulate and support shared and multidisciplinary evidence-based treatment in diabetes-related foot disease. In this special virtual issue of Diabetes/Metabolism Research and Reviews, all 21 documents of the 2023 update of the IWGDF Guidelines are bundled, added with a further 6 reviews from multidisciplinary experts to drive future research and clinical innovations, based on their contributions to the International Symposium on the Diabetic Foot. We hope the readers will enjoy this special virtual issue, and widely implement the knowledge shared here in their daily clinical practice and research endeavours with the goal to improve the care for people with diabetes-related foot disease.

Podcast on How to Classify Foot Ulcers in People with Diabetes (2023 Update of the IWGDF Guidelines on Classification).

INTRODUCTION: In this podcast, we present the result of the 2023 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. METHODS: These guidelines were based on a systematic review of the available literature that identified 28 classifications addressed in 149 articles and, subsequently, expert opinion using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) methodology. We first assessed the value of each system independently and, in the second stage, chose the best one or two to be used in each clinical scenario. RESULTS: We recommend (1) for communication among healthcare professionals to use the Site, Ischaemia, Neuropathy, Bacterial infection, Area, Depth (SINBAD) classification (first option) or consider using Wound, Ischaemia, foot Infection (WIfI) system (alternative option, when the required equipment and level of expertise are 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; (2) for predicting the outcome of an ulcer in a specific individual: no existing system could be recommended; (3) for characterising a person with an infected ulcer: the use of the IDSA (Infection Diseases Society of America)/IWGDF (first option) classification or consider using the WIfI system (alternative option, when the required equipment and level of expertise are available and it is considered as feasible); (4) for characterising a person with peripheral artery disease: consider using the WIfI system as a means to stratify healing likelihood and amputation risk; (5) for the audit of outcome(s) of populations: the use of the SINBAD score. CONCLUSION: Although there is no classification that fits all purposes, it is crucial that healthcare professionals standardize the way they characterise diabetes-related foot ulcers and guide their decision-making process by using validated classification systems.

Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: A systematic review.

BACKGROUND: It is critical that interventions used to enhance the healing of chronic foot ulcers in diabetes are backed by high-quality evidence and cost-effectiveness. In previous years, the systematic review accompanying guidelines published by the International Working Group of the Diabetic Foot performed 4-yearly updates of previous searches, including trials of prospective, cross-sectional and case-control design. AIMS: Due to a need to re-evaluate older studies against newer standards of reporting and assessment of risk of bias, we performed a whole new search from conception, but limiting studies to randomised control trials only. MATERIALS AND METHODS: For this systematic review, we searched PubMed, Scopus and Web of Science databases for published studies on randomised control trials of interventions to enhance healing of diabetes-related foot ulcers. We only included trials comparing interventions to standard of care. Two independent reviewers selected articles for inclusion and assessed relevant outcomes as well as methodological quality. RESULTS: The literature search identified 22,250 articles, of which 262 were selected for full text review across 10 categories of interventions. Overall, the certainty of evidence for a majority of wound healing interventions was low or very low, with moderate evidence existing for two interventions (sucrose-octasulfate and leucocyte, platelet and fibrin patch) and low quality evidence for a further four (hyperbaric oxygen, topical oxygen, placental derived products and negative pressure wound therapy). The majority of interventions had insufficient evidence. CONCLUSION: Overall, the evidence to support any other intervention to enhance wound healing is lacking and further high-quality randomised control trials are encouraged.

Motivation communication training programme for healthcare professionals to support adherence in patients with diabetic foot ulcers: Proof of concept study.

Patients with diabetic foot ulcers have poor adherence to treatment recommendations. However, the most effective way to support adherence in this population is unknown. This study aimed to assess the preliminary effectiveness of a motivation communication training programme for healthcare professionals working with these patients, using theory and evidence-based strategies.A proof-of-concept study using a non-randomised, controlled before-and-after design. Six podiatrists took part in the motivation communication training programme. Pre-training, observation was undertaken to examine the communication style currently used by podiatrists in routine consultations. Patients' (n = 25) perceptions of podiatrist autonomy support, self-determination for limiting weight-bearing activity and average daily step count were also assessed. Post training, observations and patient measures were repeated with a different group of patients (n = 24). Observations indicated that podiatrists exhibited a more need-supportive communication style (e.g., taking time to understand patients' perspectives) after undergoing the training programme. Patients in the post-training group reported higher levels of autonomy support, while self-determination to limit weight-bearing activity remained unchanged. Although the post-training group had a lower average daily step count, the difference was not statistically significant. This is the first study to investigate implementation of motivation communication strategies in routine consultations with patients with diabetic foot ulcers. Results suggest that training can enhance healthcare professionals' motivation communication skills with potential for addressing adherence issues, however, a larger cluster randomised controlled trial is necessary to confirm this.

Guidelines on interventions to enhance healing of foot ulcers in people with diabetes (IWGDF 2023 update).

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.

Standards for the development and methodology of the 2023 IWGDF guidelines.

AIMS: Diabetes-related foot disease is a major source of patient burden and societal costs. Investing in evidence-based international guidelines on diabetes-related foot disease is important to reduce this burden and costs, provided the guidelines are focused on outcomes important to key stakeholders and are evidence-based and properly implemented. MATERIALS AND METHODS: The International Working Group on the Diabetic Foot (IWGDF) has published and updated international guidelines since 1999. The 2023 updates were made using the Grading of Recommendations Assessment Development and Evaluation evidence-to-decision framework. This concerns formulating relevant clinical questions and important outcomes, conducting systematic reviews of the literature and meta-analyses where appropriate, completing summary of judgement tables, and writing recommendations that are specific, unambiguous and actionable, along with their transparent rationale. RESULTS: We herein describe the development of the 2023 IWGDF Guidelines on the prevention and management of diabetes-related foot disease, which consists of seven chapters, each prepared by a separate working group of international experts. These chapters provide guidelines related to diabetes-related foot disease on prevention; classification of diabetes-related foot ulcer, offloading, peripheral artery disease, infection, wound healing interventions, and active Charcot neuro-osteoarthropathy. Based on these seven guidelines, the IWGDF Editorial Board also produced a set of practical guidelines. Each guideline underwent extensive review by the members of the IWGDF Editorial Board as well as independent international experts in each field. CONCLUSIONS: We believe that the adoption and implementation of the 2023 IWGDF guidelines by healthcare providers, public health agencies, and policymakers will improve the prevention and management of diabetes-related foot disease, and subsequently reduce the worldwide patient and societal burden caused by this disease.

The International Working Group on the Diabetic Foot: Stories and Numbers Behind Three Decades of Evidence-Based Guidelines for the Management of Diabetes-Related Foot Disease.

Foot disease is a devastating complication of diabetes. For almost 3 decades, the mission of the International Working Group on the Diabetic Foot (IWGDF) is to produce evidence-based guidelines to inform health care providers worldwide on strategies for the prevention and management of diabetes-related foot disease. In this publication, we aim to better inform the reader about 'the story behind' the IWGDF Guidelines and thus facilitate improved uptake of the recommendations described in the guidelines. The first IWGDF Guidelines were published in 1999, and these have been successfully updated every 4 years since. With each update, IWGDF has improved the methodological rigour and extended the topics covered. This has been possible thanks to the involvement of > 100 experts from > 60 countries, all voluntarily dedicating their time. We estimate that the 2023 update of the IWGDF Guidelines required a total 10 years of full-time work, which would have cost 2 million euros if the voluntary work had been financially compensated. The IWGDF Guidelines are not only published in English but also translated to support local implementation. Currently available translations serve 2.9 billion people globally in their native language. As an independent and multidisciplinary organisation, IWGDF hopes that the 2023 update will continue to stimulate clinicians from all different disciplines to deliver the best care possible for these patients, will motivate researchers to undertake the high-quality trials needed to deliver the new evidence to advance the field further, and collectively will support people with diabetes-related foot disease to minimize their disease burdens.

Practical guidelines on the prevention and management of diabetes-related foot disease (IWGDF 2023 update).

Diabetes-related foot disease results in a major global burden for patients and the healthcare system. The International Working Group on the Diabetic Foot (IWGDF) has been producing evidence-based guidelines on the prevention and management of diabetes-related foot disease since 1999. In 2023, all IWGDF Guidelines have been updated based on systematic reviews of the literature and formulation of recommendations by multidisciplinary experts from all over the world. In addition, a new guideline on acute Charcot neuro-osteoarthropathy was created. In this document, the IWGDF Practical Guidelines, we describe the basic principles of prevention, classification and management of diabetes-related foot disease based on the seven IWGDF Guidelines. We also describe the organisational levels to successfully prevent and treat diabetes-related foot disease according to these principles and provide addenda to assist with foot screening. The information in these practical guidelines is aimed at the global community of healthcare professionals who are involved in the care of persons with diabetes. Many studies around the world support our belief that implementing these prevention and management principles is associated with a decrease in the frequency of diabetes-related lower-extremity amputations. The burden of foot disease and amputations is increasing at a rapid rate, and comparatively more so in middle to lower income countries. These guidelines also assist in defining standards of prevention and care in these countries. In conclusion, we hope that these updated practical guidelines continue to serve as a reference document to aid healthcare providers in reducing the global burden of diabetes-related foot disease.

Classification of foot ulcers in people with diabetes: A systematic review.

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.

Development of a Motivation Communication Training to Aid Diabetes-Specialist Podiatrists With Adherence Discussions.

Diabetic foot ulcers (DFUs) impact a substantial proportion of patients with diabetes, with high recurrence rates, severe complications, and significant financial burden to health care systems. Adherence to treatment advice (e.g., limiting weight-bearing activity) is low with patients reporting dissatisfaction with the way in which advice is communicated. This study aimed to address this problem via the systematic development of a motivation communication training program. The program was designed to support diabetes-specialist podiatrists in empowering patients to actively engage with treatment. The development process followed an intervention mapping approach. Needs assessment involved observations of 24 patient-practitioner consultations within a diabetes-specialist foot clinic. This informed specification of a theory of change (self-determination theory) and relevant evidence-based communication strategies (drawing from motivational interviewing). The training program was developed iteratively with changes made following feedback from five diabetic foot health care professionals. The resulting training program, consisting of six one-hour face-to-face sessions over an 8-week period, was delivered to a further six diabetes specialist podiatrists, with five participating in postprogram telephone interviews to assess acceptability. Deductive thematic analysis of interview data revealed positive aspects of the training (e.g., valuable and relevant content), ideas for improvement (e.g., online resources and context-specific video examples), the acceptability of motivation strategies, and challenges putting the strategies into practice (such as time constraints and breaking old communication habits). This study contributes to our understanding of integrating motivation principles into routine consultations and holds potential for enhancing adherence to treatment recommendations in patients living with diabetic foot ulcers.

Adherence to limiting weight-bearing activity in patients with diabetic foot ulcers: A qualitative study.

Patients with diabetic foot ulcers are advised to limit weight-bearing activity for ulcers to heal. Patients often disregard this advice although the reasons are not yet fully understood. This study explored (1) patients' experiences of receiving the advice and (2) factors influencing adherence to the advice. Semi-structured interviews were conducted with 14 patients with diabetic foot ulcers. Interviews were transcribed and analysed using inductive thematic analysis. Advice regarding limiting weight-bearing activity was described by patients as directive, generic and conflicting with other priorities. Rapport, empathy and rationale supported receptivity to the advice. Barriers and facilitators to limiting weight-bearing activity included demands of daily living, enjoyment of exercise, sick/disabled identity and burden, depression, neuropathy/pain, health benefits, fear of negative consequences, positive feedback, practical support, weather and active/passive role in recovery. It is important that healthcare professionals pay attention to how limiting weight-bearing activity advice is communicated. We propose a more person-centred approach in which advice is tailored to individuals' specific needs with discussion around patient priorities and constraints.

The Charcot Foot Reflects a Response to Injury That Is Critically Distorted by Preexisting Nerve Damage: An Imperfect Storm.

It has been recognized since comprehensive descriptions by Jean-Martin Charcot in 1868 and 1883 that development of what is usually known as neuropathic osteoarthropathy (or the Charcot foot) requires the coincidence of neuropathy and inflammation. Despite this, detailed understanding of the causes has remained remarkably limited in the succeeding century and a half. The aim of this descriptive account is to draw particular attention to the processes involved in both the onset and resolution of the inflammation that is an essential component of active disease. The principal observation is that while neuropathy is common in people with diabetes, the inflammation and secondary skeletal damage that characterize neuropathic osteoarthropathy are observed in only a small minority of people with diabetes and with neuropathy. We therefore argue that the key to understanding the causes of the Charcot foot is to focus equally on those who have active disease as well as those who do not. Although neuropathy is essential for development of the disorder, neuropathy also has an adverse impact on the mechanisms involved in the onset of inflammation, and these may be critically affected in the majority of those who are susceptible. The Charcot foot is uncommon in people with diabetes (or any other cause of neuropathy) because the large majority of those with neuropathy may have also lost the capacity to mount the specific inflammatory reaction that is essential for its development.

The effectiveness of systemic antibiotics for osteomyelitis of the foot in adults with diabetes mellitus: a systematic review protocol.

BACKGROUND: Osteomyelitis of the foot is a major complication of diabetes that can be limb and life threatening. Systemic antibiotic pharmacotherapy is often used first line to eradicate infection and allow restoration of devitalised bone. The aim is to conduct a systematic review of the effectiveness of systemic antibiotics on osteomyelitis of the foot in adults with diabetes mellitus. METHODS: A systematic review of all interventional studies treating osteomyelitis with systemic antibiotics in participants with diabetes mellitus and an ulcer of the foot below the malleoli will be conducted. Studies not available in English and in people below the age of 18 will be excluded. Study selection will follow the Patient Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA-P guidelines). The quality of the studies will be assessed using the Cochrane risk-of-bias tool (RoB 2) for all randomised controlled trials and the Newcastle-Ottawa Scale (NOS) will be used for non-randomised controlled trials. Electronic databases will be searched with no timeline restrictions. DATA EXTRACTION: All identified references will be imported to the Rayyan Application. Studies for eligibility will be screened by two reviewers. One reviewer will perform the data extraction and quality appraisal will be conducted by two authors. If sufficient data is available, the quality will be analysed and a meta-analysis will be performed. Data synthesis will be conducted, and meta-analysis undertaken using RevMan 5.4.1 Meta-analysis software. Non-parametric data may be compared between selective intervention and outcomes. DISCUSSION: The results of this systematic review will identify the effectiveness of systemic antibiotic therapy on osteomyelitis of the foot in people with diabetes based on the set outcome measure criteria. The findings will establish if there are existing consistent standards or variation in practice when treating diabetic foot osteomyelitis (DFO). The study may establish if guidelines are required to standardise practice when treating DFO with systemic antibiotic therapy. This systematic review protocol will synthesise the existing evidence on the effectiveness of systemic antibiotic therapy for treating DFO. TRIAL REGISTRATION: International Prospective Register for Systematic Reviews (PROSPERO) number CRD42021245424 .

The effectiveness of a new dried human amnion derived membrane in addition to standard care in treating diabetic foot ulcers: A patient and assessor blind, randomised controlled pilot study.

Recent reviews suggest that amniotic membrane products may accelerate healing of diabetic foot ulcers. A new dried human amniotic membrane (dHAM) has been used for ocular ulcers but not for diabetic foot ulcers. This was a multi-centre, prospective, patient and observer blind, randomised controlled pilot trial, to investigate whether 2 weekly addition of the dHAM to standard care versus standard care alone increased the proportion of healed participants' index foot ulcers within 12 weeks. Thirty-one people (mean age 59.8 years, 81% male, 87% type 2 diabetes) were randomised (15 dHAM, 16 usual care). Within 12 weeks, healing occurred in 4 (27%) ulcers in the dHAM group versus 1 (6.3%) usual care group (P = .1). Percentage wound area reduction was higher in the dHAM versus control group. (P = .0057). There was no difference in AEs between the two groups. Six participants allocated to dHAM correctly identified their treatment group, although 5 in usual care incorrectly thought they were in the intervention arm. This pilot trial result is encouraging showing that this dHAM preparation is safe and promising treatment. These results will be used to design a statistically powered, definitive double blind randomised controlled trial.

Guidelines on the classification of diabetic foot ulcers (IWGDF 2019).

The International Working Group on the Diabetic Foot (IWGDF) has been publishing evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. This publication represents a new guideline addressing the use of classifications of diabetic foot ulcers in routine clinical practice and reviews those which have been published. We only consider systems of classification used for active diabetic foot ulcers and do not include those that might be used to define risk of future ulceration. The guidelines are based on a review of the available literature and on expert opinion leading to the identification of eight key factors judged to contribute most to clinical outcomes. Classifications are graded on the number of key factors included as well as on internal and external validation and the use for which a classification is intended. Key factors judged to contribute to the scoring of classifications are of three types: patient related (end-stage renal failure), limb-related (peripheral artery disease and loss of protective sensation), and ulcer-related (area, depth, site, single, or multiple and infection). Particular systems considered for each of the following five clinical situations: (a) communication among health professionals, (b) predicting the outcome of an individual ulcer, (c) as an aid to clinical decision-making for an individual case, (d) assessment of a wound, with/without infection, and peripheral artery disease (assessment of perfusion and potential benefit from revascularisation), and (d) audit of outcome in local, regional, or national populations. We recommend: (a) for communication among health professionals the use of the SINBAD system (that includes Site, Ischaemia, Neuropathy, Bacterial Infection and Depth); (b) no existing classification for predicting outcome of an individual ulcer; (c) the Infectious Diseases Society of America/IWGDF (IDSA/IWGDF) classification for assessment of infection; (d) the WIfI (Wound, Ischemia, and foot Infection) system for the assessment of perfusion and the likely benefit of revascularisation; and (e) the SINBAD classification for the audit of outcome of populations.

Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: a systematic review.

The management of diabetic foot ulcers (DFU) remains a challenge, and there is continuing uncertainty concerning optimal approaches to wound healing. The International Working Group of the Diabetic Foot (IWGDF) working group on wound healing has previously published systematic reviews of the evidence in 2008, 2012 and 2016 to inform protocols for routine care and to highlight areas which should be considered for further study. The working group has now updated this review by considering papers on the interventions to improve the healing of DFU's published between June 2014 and August 2018. Methodological quality of selected studies was independently assessed by a minimum of two reviewers using the recently published 21-point questionnaire as recommended by IWGDF/European Wound Management Association, as well as the previously incorporated Scottish Intercollegiate Guidelines Network criteria. Of the 2275 papers identified, 97 were finally selected for grading following full text review. Overall, there has been an improvement in study design and a significant rise in the number of published studies. While previous systematic reviews did not find any evidence to justify the use of newer therapies, except for negative pressure wound therapy in post-surgical wounds, in this review we found additional evidence to support some interventions including a sucrose-octasulfate dressing, the combined leucocyte, fibrin and platelet patch as well as topical application of some placental membrane products, all when used in addition to usual best care. Nonetheless, the assessment and comparison of published trials remains difficult with marked clinical heterogeneity between studies: in patient selection, study duration, standard of usual care provision and the timing and description of the clinical endpoints.

Diabetic foot ulcer classifications: A critical review.

Classification and scoring systems can help both clinical management and audit outcomes of routine care. The aim of this study was to assess published systems of diabetic foot ulcers (DFUs) to determine which should be recommended for a given clinical purpose. Published classifications had to have been validated in populations of > 75% people with diabetes and a foot ulcer. Each study was assessed for internal and external validity and reliability. Eight key factors associated with failure to heal were identified from large clinical series and each classification was scored on the number of these key factors included. Classifications were then arranged according to their proposed purpose into one or more of four groups: (a) aid communication between health professionals, (b) predict clinical outcome of individual ulcers, (c) aid clinical management decision making for an individual case, and (d) audit to compare outcome in different populations. Thirty-seven classification systems were identified of which 18 were excluded for not being validated in a population of >75% DFUs. The included 19 classifications had different purposes and were derived from different populations. Only six were developed in multicentre studies, just 13 were externally validated, and very few had evaluated reliability.Classifications varied in the number (4 - 30), and definition of individual items and the diagnostic tools required. Clinical outcomes were not standardized but included ulcer-free survival, ulcer healing, hospitalization, limb amputation, mortality, and cost. Despite the limitations, there was sufficient evidence to make recommendations on the use of particular classifications for the indications listed above.

Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update).

The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. In conjunction with advice from internal and external reviewers and expert consultants in the field, this update is based on a systematic review of the literature centred on the following: the Population (P), Intervention (I), Comparator (C) and Outcomes (O) framework; the use of the SIGN guideline/Cochrane review system; and the 21 point scoring system advocated by IWGDF/EWMA. This has resulted in 13 recommendations. The recommendation on sharp debridement and the selection of dressings remain unchanged from the last recommendations published in 2016. The recommendation to consider negative pressure wound therapy in post-surgical wounds and the judicious use of hyperbaric oxygen therapy in certain non-healing ischaemic ulcers also remains unchanged. Recommendations against the use of growth factors, autologous platelet gels, bioengineered skin products, ozone, topical carbon dioxide, nitric oxide or interventions reporting improvement of ulcer healing through an alteration of the physical environment or through other systemic medical or nutritional means also remain. New recommendations include consideration of the use of sucrose-octasulfate impregnated dressings in difficult to heal neuro-ischaemic ulcers and consideration of the use of autologous combined leucocyte, platelet and fibrin patch in ulcers that are difficult to heal, in both cases when used in addition to best standard of care. A further new recommendation is the consideration of topical placental derived products when used in addition to best standard of care.