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 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 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.     

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.     

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.     

Effectiveness of revascularisation of the ulcerated foot in patients with diabetes and peripheral artery disease: A systematic review

In patients with diabetes, foot ulceration and peripheral artery disease (PAD), it is often difficult to determine whether, when and how to revascularise the affected lower extremity. The presence of PAD is a major risk factor for non‐healing and yet clinical outcomes of revascularisation are not necessarily related to technical success. The International Working Group of the Diabetic Foot updated systematic review on the effectiveness of revascularisation of the ulcerated foot in patients with diabetes and PAD is comprised of 64 studies describing >13 000 patients. Amongst 60 case series and 4 non‐randomised controlled studies, we summarised clinically relevant outcomes and found them to be broadly similar between patients treated with open vs endovascular therapy. Following endovascular revascularisation, the 1 year and 2 year limb salvage rates were 80% (IQR 78‐82%) and 78% (IQR 75‐83%), whereas open therapy was associated with rates of 85% (IQR 80‐90%) at 1 year and 87% (IQR 85‐88%) at 2 years, however these results were based on a varying combination of studies and cannot therefore be interpreted as cumulative. Overall, wound healing was achieved in a median of 60% of patients (IQR 50‐69%) at 1 year in those treated by endovascular or surgical therapy, and the major amputation rate of endovascular vs open therapy was 2% vs 5% at 30 days, 10% vs 9% at 1 year and 13% vs 9% at 2 years. For both strategies, overall mortality was found to be high, with 2% (1‐6%) perioperative (or 30 day) mortality, rising sharply to 13% (9‐23%) at 1 year, 29% (19‐48%) at 2 years and 47% (39‐71%) at 5 years. Both the angiosome concept (revascularisation directly to the area of tissue loss via its main feeding artery) or indirect revascularisation through collaterals, appear to be equally effective strategies for restoring perfusion. Overall, the available data do not allow us to recommend one method of revascularisation over the other and more studies are required to determine the best revascularisation approach in diabetic foot ulceration.     

Performance of prognostic markers in the prediction of wound healing or amputation among patients with foot ulcers in diabetes: A systematic review

Clinical outcomes of patients with diabetes, foot ulceration, and peripheral artery disease (PAD) are difficult to predict. The prediction of important clinical outcomes, such as wound healing and major amputation, would be a valuable tool to help guide management and target interventions for limb salvage. Despite the existence of a number of classification tools, no consensus exists as to the most useful bedside tests with which to predict outcome. We here present an updated systematic review from the International Working Group of the Diabetic Foot, comprising 15 studies published between 1980 and 2018 describing almost 6800 patients with diabetes and foot ulceration. Clinical examination findings as well as six non‐invasive bedside tests were evaluated for their ability to predict wound healing and amputation. The most useful tests to inform on the probability of healing were skin perfusion pressure ≥ 40 mmHg, toe pressure ≥ 30 mmHg, or TcPO₂ ≥ 25 mmHg. With these thresholds, all of these tests increased the probability of healing by greater than 25% in at least one study. To predict major amputation, the most useful tests were ankle pressure < 50 mmHg, ABI < 0.5, toe pressure < 30 mmHg, and TcPO₂ < 25 mmHg, which increased the probability of major amputation by greater than 25%. These indicative values may be used as a guide when deciding which patients are at highest risk for poor outcomes and should therefore be evaluated for revascularization at an early stage. However, this should always be considered within the wider context of important co‐existing factors such as infection, wound characteristics, and other comorbidities.     

Effectiveness of bedside investigations to diagnose peripheral artery disease among people with diabetes mellitus: A systematic review

The accurate identification of peripheral artery disease (PAD) in patients with diabetes and foot ulceration is important, in order to inform timely management and to plan intervention including revascularisation. A variety of non‐invasive tests are available to diagnose PAD at the bedside, but there is no consensus as to the most useful test, or the accuracy of these bedside investigations when compared to reference imaging tests such as magnetic resonance angiography, computed tomography angiography, digital subtraction angiography or colour duplex ultrasound. Members of the International Working Group of the Diabetic Foot updated our previous systematic review, to include all eligible studies published between 1980 and 2018. Some 15 380 titles were screened, resulting in 15 eligible studies (comprising 1563 patients, of which >80% in each study had diabetes) that evaluated an index bedside test for PAD against a reference imaging test. The primary endpoints were positive likelihood ratio (PLR) and negative likelihood ratio (NLR). We found that the most commonly evaluated test parameter was ankle brachial index (ABI) <0.9, which may be useful to suggest the presence of PAD (PLR 6.5) but an ABI value between 0.9 and 1.3 does not rule out PAD (NLR 0.31). A toe brachial index >0.75 makes the diagnosis of PAD less likely (NLR 0.14‐0.24), whereas pulse oximetry may be used to suggest the presence of PAD (if toe saturation < 2% lower than finger saturation; PLR 17.23‐30) or render PAD less likely (NLR 0.2‐0.27). We found that the presence of triphasic tibial waveforms has the best performance value for excluding a diagnosis of PAD (NLR 0.09‐0.28), but was evaluated in only two studies. In addition, we found that beside clinical examination (including palpation of foot pulses) cannot reliably exclude PAD (NLR 0.75), as evaluated in one study. Overall, the quality of data is generally poor and there is insufficient evidence to recommend one bedside test over another. While there have been six additional publications in the last 4 years that met our inclusion criteria, more robust evidence is required to achieve consensus on the most useful non‐invasive bedside test to diagnose PAD.     

国际糖尿病足工作组《糖尿病足溃疡周围动脉病变诊断、预后与管理指南(2019版)》解读

国际糖尿病足工作组《糖尿病足溃疡周围动脉病变诊断、预后与管理指南(2019版)》在2015版的基础上进行了内容的更新。按照患者-干预-比较-结局(PICO)原则,编委会提出8个临床问题,在循证医学基础上进行文献系统评价,从诊断、预后和管理3个方面提出了17条建议,从而指导从事糖尿病足的医护人员在周围动脉病变方面规范诊断...     

Frequency of risk factors for foot ulceration in individuals with chronic kidney disease

Background: Although chronic kidney disease (CKD) has been associated with foot ulceration, the pathological pathway involved remains unclear. This pilot study was designed to investigate the risk factors for foot ulceration in individuals with CKD who do not have diabetes. The aims of this study were to establish the risk status for foot ulceration in individuals with CKD and to identify the particular foot ulcer risk factors most prevalent in this group. Methods: One hundred outpatients were recruited from a metropolitan hospital and allocated into one of four groups: (i) control: neither diabetes nor CKD, (ii) diabetes alone, (iii) coexisting CKD and diabetes and (iv) CKD alone. All participants were assessed for past/current foot ulcers, peripheral neuropathy, vascular insufficiency, structural deformity and skin pathology. Comparisons were made between the groups regarding the prevalence of these factors. Results: Participants with CKD who did not have diabetes displayed no significant differences in risk factor presentation from those with diabetes alone. Of the participants with CKD and no diabetes, 36% had peripheral neuropathy, 20% had vascular insufficiency and 24% had the copresentation of peripheral neuropathy and structural deformity. Overall, participants with both CKD and diabetes had the highest presentation of past/current foot ulcers, peripheral neuropathy and vascular insufficiency, all significantly more frequent in this group than in controls (P < 0.05). Eight of the total 10 participants found to have a past/current foot ulcer were in end‐stage kidney failure. Conclusion: Individuals with CKD frequently display risk factors for foot ulceration. Risk factors are more prevalent in individuals who also have diabetes and foot ulcers become more frequent with progression to end‐stage kidney failure. Risk assessment and patient awareness strategies should therefore be extended to include all patients with CKD so as to reduce future foot ulcer development.     

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.     

澳门住院截肢患者的临床特点及预后分析

目的调查分析澳门仁伯爵综合医院近5年截肢患者的临床特点、预后及危险因素。方法回顾性分析2011年1月至2016年12月澳门仁伯爵综合医院截肢患者,记录截肢患者的人口学资料、截肢原因、截肢危险因素、截肢平面以及伴随疾病等进行分析。多因素logistic回归分析疾病危险因素对截肢平面的影响。采用Kaplan-Meier法对截肢后患者生存时间做生存分析。结果共有175例住院患者进行了208次截肢手术,年龄(70.3±14.1)岁。其中膝上截肢71例,膝下截肢51例,足部截肢或截趾86例。130例因糖尿病足截肢,41例因糖尿病足合并下肢血管病变截肢,19例因下肢血管病变截肢,18例因其他原因截肢。多因素logistic回归分析结果表明高血压和下肢血管病患者更易发生膝上截肢(RR值分别为2.012,1.914,P值分别为0·215,0.107),糖尿病患者更易发生足部截肢(RR=0.315,=0.019)。Kaplan-Meier生存分析结果表明截肢平面对于患者生存期有一定影响,膝上截肢患者术后生存期最短。结论澳门仁伯爵综合医院截肢患者最常见的原因是糖尿病足,其次为下肢血管病变,其他原因包括创伤、肿瘤等。截肢平面与患者的心血管病危险因素与伴随疾病有关。截肢患者术后生存期较短,截肢平面是影响术后生存期的一个因素。     

The impact of coronary artery disease and left ventricular ejection fraction on the prognosis of patients with peripheral artery disease

The impact of the severity of coronary artery disease (CAD) and left ventricular ejection fraction (LVEF) on the prognosis of patients with peripheral artery disease (PAD) has not been systematically studied. We retrospectively analysed 622 patients with PAD (intermittent claudication (IC): n = 446; critical limb ischaemia (CLI): n = 176). The association of SYNTAX score and LVEF with mortality was analysed using the Cox proportional hazard model. In patients with IC, a high SYNTAX score was significantly associated with mortality, whereas reduced LVEF was significantly associated with mortality in patients with CLI. The prognostic impact of CAD and LVEF appears different between patients with IC and CLI.     

Clinical outcome of diabetes patients hospitalized with foot ulcers, Dar es Salaam, Tanzania.

AIMS: To determine the prevalence rate, clinical features, risk factors, and clinical outcome of foot ulcers in diabetes patients admitted to Muhimbili National Hospital, Dar es Salaam, Tanzania. METHODS: A prospective cohort study of newly hospitalized, adult diabetes patients with foot ulcers was conducted during January 1997 to December 1998 (study period). Detailed clinical and epidemiological data were recorded for each patient, followed by a comprehensive physical examination. Clinical outcome was documented. RESULTS: Of 627 diabetes patients evaluated during the study period, 92 (15%) had foot ulcers. Of these 92 patients, 30 (33%) were selected for surgery (minor and major amputations); the rest were managed conservatively. Patients who underwent surgery were more likely than those who did not to have gangrene (P < 0.001) or neuropathy (P < 0.01). On stratification by severity of ulcers, patients with Wagner score > or = 4 were significantly more likely than those < 4 to have neuroischaemic foot lesions (P < 0.001) or delayed presentation to hospital (P < 0.001). The overall mortality rates for amputees and non-amputees were similar (29%); the highest in-patient mortality rate (54%) was observed among patients with severe (Wagner grade > or = 4) ulcers who did not undergo surgery. CONCLUSIONS: Diabetic foot ulcers are associated with significant morbidity and mortality in Tanzania. Mortality rates among patients with severe ulcers remain high despite surgery. Thus, surgery undertaken during the less severe stages of ulcers may improve patient outcome. Education of patients should underscore the importance of foot care and consulting a doctor during the early stages of foot ulcer disease.     

Transcutaneous oxygen tension monitoring after successful revascularization in diabetic patients with ischaemic foot ulcers.

OBJECTIVE: To monitor transcutaneous oxygen tension (TcPO2) after percutaneous transluminal angioplasty (PTA) in diabetic patients with ischaemic foot ulcers. RESEARCH DESIGN AND METHODS: Twenty-three diabetic patients with ischaemic foot ulcers who underwent successful revascularization by PTA (SR group) were retrospectively selected. Twenty diabetic patients who underwent unsuccessful revascularization (UR group) were also included. Transcutaneous oxygen tension was measured at the dorsum of the foot before and 1 (+/- 1), 7 (+/- 1), 14 (+/- 1), 21 (+/- 1) and 28 (+/- 1) days after the surgical procedure. RESULTS: After PTA, TcPO2 progressively improved in the SR group, reaching its peak 4 weeks after angioplasty. A concomitant decrease of cutaneous carbon dioxide tension (TcPCO2) was also observed immediately after PTA which reached the lowest levels 3 weeks later. In the UR group, TcPO2 showed a slight improvement immediately after PTA but remained stable throughout the observation, while TcPCO2 levels did not change. Finally, the percentage of SR patients with a TcPO2 > or = 30 mmHg was 38.5% 1 week after PTA, while it increased to 75% 3 weeks later. CONCLUSION: Transcutaneous oxygen tension monitoring showed that after successful revascularization it takes 3-4 weeks for cutaneous oxygenation to improve and reach the optimal levels for wound healing. Transcutaneous carbon dioxide tension monitoring may be more useful to identify the negative outcome of a revascularization procedure. Our findings suggest that, when the surgical approach can be delayed, the best timing to perform a more aggressive debridement or minor amputations is 3-4 weeks after successful revascularization.