Guidelines on offloading foot ulcers in persons with 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. This guideline is on the use of offloading interventions to promote the healing of foot ulcers in people 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 nonremovable 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 nonremovable 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 ischaemia 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, hospitalization, and amputation.     

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.     

Guidelines on the prevention of foot ulcers in persons with 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. 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 health care professionals to provide better care for persons with diabetes at risk of foot ulceration, to increase the number of ulcer‐free days, and to reduce the patient and health care burden of diabetic foot disease.     

Guidelines on the diagnosis and treatment of foot infection in persons with 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. This guideline is on the diagnosis and treatment of foot infection in persons with diabetes and updates the 2015 IWGDF infection guideline. On the basis of patient, intervention, comparison, outcomes (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 2015), 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.     

Guidelines on diagnosis,prognosis, and management of peripheral artery disease in patients with foot ulcers and 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. This guideline is on the diagnosis, prognosis, and management of peripheral artery disease (PAD) 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 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 subset of patients. We followed the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology to devise clinical questions and critically important outcomes in the patient‐intervention‐comparison‐outcome (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.     

Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update)

Diabetic foot disease results in a major global burden for patients and the health care system. The International Working Group on the Diabetic Foot (IWGDF) has been producing evidence‐based guidelines on the prevention and management of diabetic foot disease since 1999. In 2019, 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 this document, the IWGDF Practical Guidelines, we describe the basic principles of prevention, classification, and treatment of diabetic foot disease, based on the six IWGDF Guideline chapters. We also describe the organizational levels to successfully prevent and treat diabetic 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 health care 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. We hope that these updated practical guidelines continue to serve as reference document to aid health care providers in reducing the global burden of diabetic foot disease.     

Matrix metalloproteinases and diabetic foot ulcers: the ratio of MMP-1 to TIMP-1 is a predictor of wound healing

Aims Matrix metalloproteinases (MMPs) play a major role in wound healing: they can degrade all components of the extracellular matrix. In diabetic foot ulcers there is an excess of MMPs and a decrease of the tissue inhibitors of MMPs (TIMPs). This imbalance is probably one cause of impaired healing. However, little is known about changes in MMPs during wound healing. Methods Sixteen patients with neuropathic diabetic foot ulcers participated. Wound fluid was collected regularly during the 12-week follow-up period, for measurement of MMP-1, MMP-2, MMP-8, MMP-9 and TIMP-1. Results were analysed by the degree of wound healing: good healers (defined by a reduction of at least 82% in initial wound surface at 4 weeks) and poor healers (reduction of less than 82% in wound surface at 4 weeks). Results In good healers, levels of MMP-8 and -9 secreted by inflammatory cells decreased earlier. The initial levels of MMP-1 were similar in good and poor healers (P = 0.1) but rose significantly at week 2 in good healers (P = 0.039). There was a significant correlation between a high ratio of MMP-1/TIMP-1 and good healing (r = 0.65, P = 0.008). Receiver Operator Curve (ROC) analysis showed that an MMP-1/TIMP-1 ratio of 0.39 best predicted wound healing (sensitivity = 71%, specificity = 87.5%). Conclusions A high level of MMP-1 seems essential to wound healing, while an excess of MMP-8 and -9 is deleterious, and could be a target for new topical treatments. The MMP-1/TIMP-1 ratio is a predictor of wound healing in diabetic foot ulcers.     

Dysregulation of wound healing mechanisms in diabetes and the importance of negative pressure wound therapy (NPWT)

Diabetes is a serious disease with severe side effects and comorbidities. Diabetic foot with its chronic nonhealing ulcers, or diabetic foot ulcers, as they are commonly called, can be devastating, even leading to amputation. Many therapies exist to assist and improve wound healing. One exciting discovery is the use of negative pressure wound therapy (NPWT) as an adjunct to standard treatment. Few studies have substantively explored the molecular mechanisms of NPWT and why we see improved wound healing, a concept that demands more research. The following commentary summarizes the current literature regarding NPWT as well as some of the vast body of work that focuses on the physiologic mechanisms of wound healing in diabetics in general.     

The effects of applied felted foam on wound healing and healing times in the therapy of neuropathic diabetic foot ulcers.

AIMS: The application of felted foam is a promising method for plantar pressure reduction in the ulcer region of diabetic foot ulcers, but knowledge of its effects on wound healing is sparse. The objective of this study was to evaluate the effects of felted foam on wound healing in diabetic foot ulcers compared with a standard method of plantar pressure relief. MATERIALS AND METHODS: A total of 54 Type 1 or Type 2 diabetic patients with neuropathic diabetic foot ulcers were evaluated in this prospective randomized controlled study. Ulcer healing was assessed by planimetric measurement of the wound area at beginning of the study and after 10 weeks and at least until wound healing. The patients were consecutively enrolled in the study; 24 patients were randomized to the felted foam therapy, and 30 patients were randomized to conventional therapy. RESULTS: In the felted foam group, the initial average wound area was 102.3 +/- 45.3 mm2 (mean +/- sd), and 5.4 +/- 3.1 mm2 after 10 weeks with an average healing time of 75 days [95% confidence interval (CI) 67-84]. In the conventional therapy group, the initial average wound area was 112.5 +/- 50.8 mm2, and 10.6 +/- 4.2 mm2 after 10 weeks with an average healing time of 85 days (95% CI 79-92) (P = 0.03). The mean wound radius decreased by 0.48 mm (95% CI 0.42-0.56) per week in the felted foam group and by 0.39 mm (95% CI 0.35-0.42) per week in the conventional group (P = 0.005). CONCLUSIONS: The felted foam technique appears to be at least as effective as conventional plantar ulcer treatment. It may be a useful alternative in treating neuropathic foot ulceration, especially in patients who are not able to avoid weight-bearing reliably.     

Unresolved issues in the management of ulcers of the foot in diabetes

Management of diabetic foot ulcers presents a major clinical challenge. The response to treatment is often poor and the outcome disappointing, while the costs are high for both healthcare providers and the patient. In such circumstances, it is essential that management should be based on firm evidence and follow consensus. In the case of the diabetic foot, however, clinical practice can vary widely. It is for these reasons that the International Working Group on the Diabetic Foot has published guidelines for adoption worldwide. The Group has now also completed a series of non‐systematic and systematic reviews on the subjects of soft tissue infection, osteomyelitis, offloading and other interventions designed to promote ulcer healing. The current article collates the results of this work in order to demonstrate the extent and quality of the evidence which is available in these areas. In general, the available scientific evidence is thin, leaving many issues unresolved. Although the complex nature of diabetic foot disease presents particular difficulties in the design of robust clinical trials, and the absence of published evidence to support the use of an intervention does not always mean that the intervention is ineffective, there is a clear need for more research in the area. Evidence from sound clinical studies is urgently needed to guide consensus and to underpin clinical practice. It is only in this way that patients suffering with these frequently neglected complications of diabetes can be offered the best hope for a favourable outcome, at the least cost.     

Use of sugar on the healing of diabetic ulcers: a review

With the advent of several innovative wound care management tools, the choice of products and treatment modalities available to clinicians continues to expand. High costs associated with wound care, especially diabetic foot wounds, make it important for clinician scientists to research alternative therapies and optimally incorporate them into wound care protocols appropriately. This article reviews using sugar as a treatment option in diabetic foot care and provides a guide to its appropriate use in healing foot ulcers. In addition to a clinical case study, the physiological significance and advantages of sugar are discussed.     

Diabetic foot disease: “The Times They are A Changin’ ”

Diabetic foot disease greatly impacts both affected patients and society, but remains the “Cinderella” of diabetes‐related complications. However, recent progress in research and guideline development have led to increased awareness of the problem and improved clinical outcomes. Thus, it is time for a shift in global perception of this increasingly prevalent problem. In this special issue, we present 7 up‐to‐date clinical guidelines and 10 systematic reviews developed by the International Working Group on the Diabetic Foot, together with 17 informative and stimulating related papers. These guidelines offer new recommendations on ulcer classification, diagnosis of infection severity, and vascular assessment, to assist in ulcer risk stratification, diagnosis and interdisciplinary communication. Key developments include providing guidance on methodological assessment of research papers; expanding the evidence base for ulcer treatment by the use of wound products and offloading treatment and suggestions for improving ulcer prevention through technological advances in patient monitoring of risk factors and footwear. The 17 invited papers discuss related topics ranging from stem cell research to patient psychology and describe the way forward in diabetic foot care. While there is much more to learn, the new knowledge of underlying pathways, advancements in diagnosis, treatment and prevention presented in this supplement should help improve outcomes and reduce the great and growing burden of diabetic foot disease.     

Systematic review of methods to diagnose infection in foot ulcers in diabetes.

AIM: To undertake a systematic review of the diagnostic performance of clinical examination, sample acquisition and sample analysis in infected foot ulcers in diabetes. METHODS: Nineteen electronic databases plus other sources were searched. To be included, studies had to fulfil the following criteria: (i) compare a method of clinical assessment, sample collection or sample analysis with a reference standard; (ii) recruit diabetic individuals with foot ulcers; (ii) present 2 x 2 diagnostic data. Studies were critically appraised using a 12-item checklist. RESULTS: Three eligible studies were identified, one each on clinical examination, sample collection and sample analysis. For all three, study groups were heterogeneous with respect to wound type and a small proportion of participants had foot ulcers due to diabetes. No studies identified an optimum reference standard. Other methodological problems included non-blind interpretation of tests and the time lag between index and reference tests. Individual signs or symptoms of infection did not prove to be useful tests when assessed against punch biopsy as the reference standard. The wound swab did not perform well when assessed against tissue biopsy. Semiquantitative analysis of wound swab might be a useful alternative to quantitative analysis. The limitations of these findings and their impact on recommendations from relevant clinical guidelines are discussed. CONCLUSION: Given the importance of this topic, it is surprising that only three eligible studies were identified. It was not possible to describe the optimal methods of diagnosing infection in diabetic patients with foot ulceration from the evidence identified in this systematic review.     

Offloading of diabetes-related neuropathic foot ulcers at Swedish prosthetic and orthotic clinics

Aims

This study aimed to assess (1) the use of different offloading interventions in Sweden for the healing of diabetes-related plantar neuropathic forefoot ulcers, (2) factors influencing the offloading intervention choice, and (3) the awareness of current gold standard offloading devices.

Methods

An online questionnaire was distributed via SurveyMonkey to 51 prosthetic and orthotic clinics in Sweden.

Results

Thirty-five (69%) practitioners responded to the questionnaire. Eighty-six percent of the practitioners provided modified off-the-shelf footwear combined with insoles to treat diabetes-related plantar neuropathic forefoot ulcers. A total contact cast (TCC) was provided by 20% of the practitioners, and a nonremovable knee-high walker was provided by 0%. Multiple practitioner-, patient-, intervention-, and wound-related factors were considered when practitioners provided offloading interventions to patients with this type of ulcer. The majority of the practitioners did not or were unsure whether they considered TCC or a nonremovable knee-high walker to be the gold standard treatment.

Conclusions

Practitioners mainly provided the offloading intervention that the International Working Group on the Diabetic Foot strongly recommends not be provided, namely, modified off-the-shelf footwear with insoles. In contrast, TCC and nonremovable knee-high walkers, as the gold standards, were vastly underutilised. Therefore, the pattern of providing offloading interventions was almost exactly opposite to the recommendations of evidence-based guidelines. Different factors were considered when providing offloading interventions to patients with diabetes-related plantar neuropathic forefoot ulcers. The practitioners' lack of awareness regarding gold standard devices may have contributed to the underutilisation of TCC and nonremovable knee-high walkers.