IWGDF Guidelines

This guideline is on the prevention of foot ulceration in persons with diabetes and updates the 2015 IWGDF prevention guideline.

We followed the GRADE methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where evidence was not available, and a weighing of the benefits and harms, patient preferences, feasibility and applicability, and costs related to the intervention.

We recommend to screen a person at very low risk for ulceration annually for loss of protective sensation and peripheral artery disease, and persons at higher risk at higher frequencies for additional risk factors. For preventing a foot ulcer, educate the at-risk patient about appropriate foot self-care and treat any pre-ulcerative sign on the foot. Instruct moderate-to-high risk patients to wear accommodative properly fitting therapeutic footwear, and consider instructing them to monitor foot skin temperature. Prescribe therapeutic footwear that has a demonstrated plantar pressure relieving effect during walking to prevent plantar foot ulcer recurrence. In patients that fail non-surgical treatment for an active or imminent ulcer, consider surgical intervention; we suggest not to use a nerve decompression procedure. Provide integrated foot care for high-risk patients to prevent ulcer recurrence.

Following these recommendations will 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 diabetic foot disease.

Prevention guideline - IWGDF website

This guideline is on the use of offloading interventions to promote healing foot ulcers in persons with diabetes and updates the previous IWGDF guideline.

We followed the GRADE methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where evidence was not available, and a weighing of the benefits and harms, patient preferences, feasibility and applicability, and costs related to the intervention.

For healing a neuropathic plantar forefoot or midfoot ulcer in a person with diabetes, we recommend that a non-removable knee-high offloading device is the first-choice of offloading treatment. A removable knee-high and removable ankle-high offloading device are to be considered as the second- and third-choice offloading treatment, respectively, if contraindications or patient intolerance to non- removable offloading exist. Appropriately fitting footwear combined with felted foam can be considered as the fourth-choice offloading treatment. If non-surgical offloading fails, we recommend to consider surgical offloading interventions for healing metatarsal head and digital ulcers. We have added new recommendations for the use of offloading treatment for healing ulcers that are complicated with infection or ischemia, and for healing plantar heel ulcers.

Offloading is arguably the most important of multiple interventions needed to heal a neuropathic plantar foot ulcer in a person with diabetes. Following these recommendations will help health care professionals and teams provide better care for diabetic patients who have a foot ulcer and are at risk for infection, hospitalisation and amputation.

Offloading guideline - IWGDF website

This guideline is on the diagnosis, prognosis and management of peripheral artery disease in patients with foot ulcers and diabetes and updates the previous IWGDF guideline.

Up to 50% of patients with diabetes and foot ulceration have concurrent peripheral artery disease (PAD), which confers a significantly elevated risk of adverse limb events and cardiovascular disease. We know that the diagnosis, prognosis and treatment of these patients are markedly different to patients with diabetes who do not have PAD and yet there are few good quality studies addressing this important sub-set of patients.

We followed the GRADE methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where evidence was not available, and a weighing of the benefits and harms, patient preferences, feasibility and applicability, and costs related to the intervention.

We here present the updated 2019 guidelines on diagnosis, prognosis and management of PAD in patients with a foot ulcer and diabetes, and we suggest some key future topics of particular research interest.

This guideline is on the diagnosis and treatment of foot infection in persons with diabetes, and updates the 2015 IWGDF infection guideline.

Based on PICOs developed by the infection committee, in conjunction with internal and external reviewers and consultants, and on systematic reviews the committee conducted on the diagnosis of infection (new) and treatment of infection (updated from 2016), we offer 27 recommendations. These cover various aspects of diagnosing soft tissue and bone infection, including the classification scheme for diagnosing infection and its severity.

Of note, we have updated this scheme for the first time since we developed it 15 years ago. We also review the microbiology of diabetic foot infections, including how to collect samples and to process them to identify causative pathogens. Finally, we discuss the approach to treating diabetic foot infections, including selecting appropriate empiric and definitive antimicrobial therapy for soft tissue and for bone infections, when and how to approach surgical treatment and which adjunctive treatments we think are or are not useful for the infectious aspects of diabetic foot problems.

For this version of the guideline we also updated four tables and one figure from the 2016 guideline. We think that following the principles of diagnosing and treating diabetic foot infections outlined in this guideline can help clinicians to provide better care for these patients.

List of recommendations

1. Remove slough, necrotic tissue and surrounding callus of a diabetic foot ulcer with sharp debridement in preference to other methods, taking relative contraindications such as pain or severe ischemia into account. (GRADE Strength of recommendation: Strong; Quality of evidence: Low)

2. Select dressings principally on the basis of exudate control, comfort and cost. (Strong; Low)

3. Do not use dressings/applications containing surface antimicrobial agents with the sole aim of accelerating the healing of an ulcer. (Strong; Low)

4. Consider the use of the sucrose-octasulfate impregnated dressing in non-infected, neuro-ischaemic diabetic foot ulcers that are difficult to heal despite best standard of care. (Weak; Moderate)

5. Consider the use of systemic hyperbaric oxygen therapy as an adjunctive treatment in non-healing ischaemic diabetic foot ulcers despite best standard of care. (Weak; Moderate)

6. We suggest not using topical oxygen therapy as a primary or adjunctive intervention in diabetic foot ulcers including those that are difficult to heal. (Weak; Low)

7. Consider the use of negative pressure wound therapy to reduce wound size, in addition to best standard of care, in patients with diabetes and a post-operative (surgical) wound on the foot. (Weak; Low)

8. As negative pressure wound therapy has not been shown to be superior to heal a non-surgical diabetic foot ulcer, we suggest not using this in preference to best standard of care. (Weak; Low)

9. Consider the use of placental derived products as an adjunctive treatment, in addition to best standard of care, when the latter alone has failed to reduce the size of the wound. (Weak; Low)

10. We suggest not using the following agents reported to improve wound healing by altering the wound biology: growth factors, autologous platelet gels, bioengineered skin products, ozone, topical carbon dioxide and nitric oxide, in preference to best standard of care. (Weak; Low)

11. Consider the use of autologous combined leucocyte, platelet and fibrin as an adjunctive treatment, in addition to best standard of care, in non-infected diabetic foot ulcers that are difficult to heal. (Weak, Moderate)

12. Do not use agents reported to have an effect on wound healing through alteration of the physical environment including through the use of electricity, magnetism, ultrasound and shockwaves, in preference to best standard of care. (Strong; Low)

13. Do not use interventions aimed at correcting the nutritional status (including supplementation of protein, vitamins and trace elements, pharmacotherapy with agents promoting angiogenesis) of patients with a diabetic foot ulcer, with the aim of improving healing, in preference to best standard of care. (Strong; Low)

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.

This guideline is 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: (i) communication among health professionals, (ii) predicting the outcome of an individual ulcer, (iii) as an aid to clinical decision-making for an individual case, (iv) assessment of a wound, with/without infection and peripheral artery disease (assessment of perfusion and potential benefit from revascularisation) and (v) audit of outcome in local, regional or national populations.

We recommend: (i) for communication among health professionals the use of the SINBAD system; (ii) no existing classification for predicting outcome of an individual ulcer; (iii) the Infectious Diseases Society of America/International Working Group on the Diabetic Foot (IDSA/IWGDF) classification for assessment of infection; (iv) the WIfI (Wound, Ischemia, foot Infection) system for the assessment of perfusion and the likely benefit of revascularisation; and (v) the SINBAD classification for the audit of outcome of populations.

Diabetic foot disease is a source of major patient suffering and societal costs. Investing in evidence-based international guidelines on diabetic foot disease is likely among the most cost-effective forms of healthcare expenditure, provided the guidelines are goal-focused, evidence-based and properly implemented.

The International Working Group on the Diabetic Foot (IWGDF) has published and updated international guidelines since 1999. The 2019 updates are based on formulating relevant clinical questions and outcomes, rigorous systematic reviews of the literature, and as specific, clear, and unambiguous as possible recommendations and their rationale, all using the Grading of Recommendations Assessment Development and Evaluation (GRADE) system.

We herein describe the development of the 2019 IWGDF Guidelines on the prevention and management of diabetic foot disease, which consist of six chapters, each prepared by a separate working group of international experts. These documents provide guidelines related to diabetic foot disease on: prevention; offloading; peripheral artery disease; infection; wound healing interventions; and, classification of diabetic foot ulcers. Based on these six chapters, 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.

We believe that if healthcare professionals follow the recommendations of the 2019 IWGDF guidelines, and when necessary adopt them to local circumstances, it will result in improved prevention and management of diabetic foot disease and a subsequent worldwide reduction in the patient and societal burden it causes.