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Diabetic foot ulcer (DFU) is a common chronic complication of diabetes. This complication is characterized by the formation of ulcers that are difficult to heal on the skin of the foot. Ulcers can negatively affect patients' quality of life, and improperly treated lesions can result in amputation and even death. Traditionally, the severity and type of foot ulcers are determined by doctors through visual observations and on the basis of their clinical experience; however, this subjective evaluation can lead to misjudgments. In addition, quantitative methods have been developed for classifying and scoring are therefore time-consuming and labor-intensive. In this paper, we propose a reconstruction residual network with a fused spatial-channel attention mechanism (FARRNet) for automatically classifying DFUs. The use of pseudo-labeling and Data augmentation as a pre-processing technique can overcome problems caused by data imbalance and small sample size. The developed model's attention was enhanced using a spatial channel attention (SPCA) module that incorporates spatial and channel attention mechanisms. A reconstruction mechanism was incorporated into the developed residual network to improve its feature extraction ability for achieving better classification. The performance of the proposed model was compared with that of state-of-the-art models and those in the DFUC Grand Challenge. When applied to the DFUC Grand Challenge, the proposed method outperforms other state-of-the-art schemes in terms of accuracy, as evaluated using 5-fold cross-validation and the following metrics: macro-average F1-score, AUC, Recall, and Precision. FARRNet achieved the F1-score of 60.81%, AUC of 87.37%, Recall of 61.04%, and Precision of 61.56%. Therefore, the proposed model is more suitable for use in medical diagnosis environments with embedded devices and limited computing resources. The proposed model can assist patients in initial identifications of ulcer wounds, thereby helping them to obtain timely treatment. [ABSTRACT FROM AUTHOR]

The Diabetic Foot Ulcer (DFU) is a severe complication that affects approximately 33% of diabetes patients globally, often leading to limb amputation if not detected early. This study introduces an automated approach for identifying and classifying DFU using transfer learning. DFU is typically categorized into ischemic and infection states, which are challenging to distinguish visually. We evaluate the effectiveness of pre-trained Deep Convolutional Neural Network (DCNN) models for autonomous DFU detection. Seven models are compared: EfficientNetB0, DenseNet121, ResNet101, VGG16, MobileNetV2, InceptionV3, and InceptionResNetV2. Additionally, we propose E-DFu-Net, a novel model derived from existing architectures, designed to mitigate overfitting. Experimental results demonstrate that E-DFu-Net achieves remarkable performance, with 97% accuracy in ischemia classification and 92% in infection classification. This advancement enhances current methodologies and aids practitioners in effectively detecting DFU cases.

Diabetic foot wounds and infections pose a significant and evolving challenge in diabetes care. Diabetic wound healing has become a major global concern for a very long time. Continuous research has been conducted to increase the healing process in diabetic ulcers to the rate of amputation. Wound healing is prolonged in diabetic patients due to various conditions, such as high glucose levels, neuropathy, poor blood circulation, and prolonged inflammation around the limbs, which causes the healing to be delayed compared to normal patients. Understanding the complexity of chronic foot wounds and the management and proper treatment would lead to a decrease in the risk of amputation. The medical team all over the world is constantly researching to lower the risk. This review paper offers a compelling journey through the multifaceted world of diabetic foot wounds and infections. It underscores the urgency of understanding classification, tackling multidrug resistance, and harnessing microbial insights to revolutionize the treatment and management of diabetic foot complications. Furthermore, it unveils state-of-the-art diagnostics, heralding a brighter future in the battle against this debilitating complication of diabetes., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Diabetes foot ulcer (DFU) is one of the common complications of diabetes patients, which may lead to infection, necrosis and even amputation. Therefore, early diagnosis, classification of severity and related treatment are crucial for the patients. Current DFU classification methods often require experienced doctors to manually classify the severity, which is time-consuming and low accuracy. The objective of the study is to propose a few-shot DFU image classification method based on deep residual neural network and transfer learning. Considering the difficulty in obtaining clinical DFU images, it is a few-shot problem. Therefore, the methods include: (1) Data augmentation of the original DFU images by using geometric transformations and random noise; (2) Deep ResNet models selection based on different convolutional layers comparative experiments; (3) DFU classification model training with transfer learning by using the selected pre-trained ResNet model and fine tuning. To verify the proposed classification method, the experiments were performed with the original and augmented datasets by separating three classifications: zero grade, mild grade, severe grade. (1) The datasets were augmented from the original 146 to 3000 image datasets and the corresponding DFU classification's average accuracy from 0.9167 to 0.9867; (2) Comparative experiments were conducted with ResNet18, ResNet34, ResNet50, ResNet101, ResNet152 by using 3000 image datasets, and the average accuracy/loss is 0.9325/0.2927, 0.9276/0.3234, 0.9901/0.1356, 0.9865/0.1427, 0.9790/0.1583 respectively; (3) Based on the augmented 3000 image datasets, it was achieved 0.9867 average accuracy with the DFU classification model, which was trained by the pre-trained ResNet50 and hyper-parameters. The experimental results indicated that the proposed few-shot DFU image classification method based on deep ResNet and transfer learning got very high accuracy, and it is expected to be suitable for low-cost and low-computational terminal equipment, aiming at helping clinical DFU classification efficiently and auxiliary diagnosis., Competing Interests: Declarations. Competing interests: The authors declare no competing interests. Ethics statement: The study was reviewed and approved by the institutional review board of Beijing Chao-Yang Hospital, Capital Medical University (ethical approval number is 2022-ke-629). All participants have signed informed consent forms., (© 2024. The Author(s).)

Aims: In addition to systemic inflammatory response syndrome (SIRS), various clinical signs, microbiological findings and inflammatory markers could be associated with severe diabetic foot infections (DFI). Methods: This study included a retrospective cohort of 245 patients with DFI treated at San Juan de Dios Hospital in San José de Costa Rica. Erythrocyte sedimentation rate (ESR), C‐reactive protein (CRP), CRP/albumin ratio, peripheral blood leucocyte ratios and the Laboratory Risk Indicator for Necrotizing Fasciitis (LRINEC) scoring system were evaluated. Univariate analysis was carried out between moderate and severe infections. ROC curves were plotted. Cut‐off value of inflammatory markers for diagnosing severe infections was established and then dichotomized to be included in a logistic regression model. A score was designed based on its results. Results: Skin necrosis (p < 0.01, OR = 8.5, 95% CI = 3.5–20.9), ESR > 94 mm/h (p < 0.01, OR = 2.5, 95% CI = 1.2–5.1), albumin < 2.8 g/dl (p = 0.04, OR = 2.0, 95% CI = 1.0–4.1) and neutrophil‐to‐lymphocyte ratio (NLR) > 4.52 (p < 0.01, OR = 3.3, 95% CI = 1.6–6.5) were found to be predictive of severe infections. Score >5 had a good diagnosis performance for classifying severe infections. Moderate infections with a score >5 had a worse prognosis than moderate ones. Conclusions: We found an association of necrosis, serum albumin, ESR and NLR values with severe DFI. The presence of these predictive factors of severity in cases of moderate infections was significantly associated with a higher rate of amputations and recurrences, longer duration of antibiotic treatment and longer hospital stays. DFI could be classified as mild, moderate, severe without SIRS and severe. [ABSTRACT FROM AUTHOR]

Background: The decision to perform amputation of a limb in a patient with diabetic foot ulcer (DFU) is not an easy task. Prediction models aim to help the surgeon in decision making scenarios. Currently there are no prediction model to determine lower limb amputation during the first 30 days of hospitalization for patients with DFU., Methods: Classification And Regression Tree analysis was applied on data from a retrospective cohort of patients hospitalized for the management of diabetic foot ulcer, using an existing database from two Orthopaedics and Traumatology departments. The secondary analysis identified independent variables that can predict lower limb amputation (mayor or minor) during the first 30 days of hospitalization., Results: Of the 573 patients in the database, 290 feet underwent a lower limb amputation during the first 30 days of hospitalization. Six different models were developed using a loss matrix to evaluate the error of not detecting false negatives. The selected tree produced 13 terminal nodes and after the pruning process, only one division remained in the optimal tree (Sensitivity: 69%, Specificity: 75%, Area Under the Curve: 0.76, Complexity Parameter: 0.01, Error: 0.85). Among the studied variables, the Wagner classification with a cut-off grade of 3 exceeded others in its predicting capacity., Conclusions: Wagner classification was the variable with the best capacity for predicting amputation within 30 days. Infectious state and vascular occlusion described indirectly by this classification reflects the importance of taking quick decisions in those patients with a higher compromise of these two conditions. Finally, an external validation of the model is still required., Level of Evidence: III., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objective: Diabetic foot ulcers (DFU) are a major sequela of uncontrolled diabetes with a high risk of adverse outcomes. Poor DFU outcomes disproportionately impact patients living in rural and economically distressed communities with lack of access to consistent, quality care. This study aimed to analyze the risk of geographic and economic disparities, including rural status and county economic distress, on the disease burden of DFU at presentation utilizing the SVS WIfI classification system., Methods: We conducted a retrospective review of 454 patients diagnosed with a DFU from 2011 to 2020 at a single institution's inpatient and outpatient wound care service. Patients >18 years old, with type II diabetes mellitus, and diabetic foot ulcer were included., Results: ANCOVA analyses showed rural patients had significantly higher WIfI composite scores (F(1,451) = 9.61, p = .002), grades of wound (F(1,439) = 11.03, p = .001), and ischemia (F(1,380) = 12.574, p = .001) compared to the urban patients. Patients that resided in at-risk economic counties had significantly higher overall WIfI composite scores (F(2,448) = 3.31, p = .037) than patients who lived in transitional economic counties, and higher foot infection grading (F(2,440) = 3.02, p = .05) compared to patients who lived in distressed economic counties. DFU patients who resided in distressed economic counties presented with higher individual grades of ischemia (F(2, 377) = 3.14, p = .04) than patients in transitional economic counties. Chi-Square analyses demonstrated patients who resided in urban counties were significantly more likely to present with grade 1 wounds (χ2(3) = 9.86, p = .02) and grade 0 ischemia (χ2(3) = 16.18, p = .001) compared to patients in rural areas. Economically distressed patients presented with significantly less grade 0 ischemia compared to patients in transitional economic counties (χ2(6) = 17.48, p = .008)., Conclusions: Our findings are the first to demonstrate the impact of geographic and economic disparities on the disease burden of DFU at presentation utilizing the SVS WIfI classification system. This may indicate need for improved multidisciplinary primary care prevention strategies with vascular specialists in these communities to mitigate worsening DFU and promote early intervention., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Classification and scoring systems can help both clinical management and audit the outcomes of routine care., Aim: This study aimed to assess published systems used to characterise ulcers in people with diabetes to determine which should be recommended to (a) aid communication between health professionals, (b) predict clinical outcome of individual ulcers, (c) characterise people with infection and/or peripheral arterial disease, and (d) audit to compare outcomes in different populations. This systematic review is part of the process of developing the 2023 guidelines to classify foot ulcers from the International Working Group on Diabetic Foot., Methods: We searched PubMed, Scopus and Web of Science for articles published up to December 2021 which evaluated the association, accuracy or reliability of systems used to classify ulcers in people with diabetes. Published classifications had to have been validated in populations of >80% of people with diabetes and a foot ulcer., Results: We found 28 systems addressed in 149 studies. Overall, the certainty of the evidence for each classification was low or very low, with 19 (68%) of the classifications being assessed by ≤ 3 studies. The most frequently validated system was the one from Meggitt-Wagner, but the articles validating this system focused mainly on the association between the different grades and amputation. Clinical outcomes were not standardized but included ulcer-free survival, ulcer healing, hospitalisation, limb amputation, mortality, and cost., Conclusion: Despite the limitations, this systematic review provided sufficient evidence to support recommendations on the use of six particular systems in specific clinical scenarios., (© 2023 John Wiley & Sons Ltd.)

Background: This publication represents a scheduled update of the 2019 guidelines of the International Working Group of the Diabetic Foot (IWGDF) addressing the use of systems to classify foot ulcers in people with diabetes in routine clinical practice. The guidelines are based on a systematic review of the available literature that identified 28 classifications addressed in 149 articles and, subsequently, expert opinion using the GRADE methodology., Methods: First, we have developed a list of classification systems considered as being potentially adequate for use in a clinical setting, through the summary of judgements for diagnostic tests, focussing on the usability, accuracy and reliability of each system to predict ulcer-related complications as well as use of resources. Second, we have determined, following group debate and consensus, which of them should be used in specific clinical scenarios. Following this process, in a person with diabetes and a foot ulcer we recommend: (a) for communication among healthcare professionals: to use the SINBAD (Site, Ischaemia, Bacterial infection, Area and Depth) system (first option) or consider using WIfI (Wound, Ischaemia, foot Infection) system (alternative option, when the required equipment and level of expertise is available and it is considered feasible) and in each case the individual variables that compose the systems should be described rather than a total score; (b) for predicting the outcome of an ulcer in a specific individual: no existing system could be recommended; (c) for characterising a person with an infected ulcer: the use of the IDSA/IWGDF classification (first option) or consider using the WIfI system (alternative option, when the required equipment and level of expertise is available and it is considered as feasible); (d) for characterising a person with peripheral artery disease: consider using the WIfI system as a means to stratify healing likelihood and amputation risk; (e) for the audit of outcome(s) of populations: the use of the SINBAD score., Conclusions: For all recommendations made using GRADE, the certainty of evidence was judged, at best, as being low. Nevertheless, based on the rational application of current data this approach allowed the proposal of recommendations, which are likely to have clinical utility., (© 2023 John Wiley & Sons Ltd.)

Background: Due to its effect on patient health and healthcare resources, the study of diabetic foot is essential. Despite the existence of classification and grading systems, further evidence is required. Current systems are prone to a lack of validation in specific populations, inadequate consideration of regional variations, and an incomplete evaluation of risk factors and outcomes. The prevalence and complications of diabetes, such as diabetic foot, are on the rise worldwide, necessitating regionally specific research. To fill these gaps, this study focuses on a Southeast Asian subpopulation., Objective: The study aims to evaluate the clinical characteristics of diabetic foot patients using the WIfI classification system, and to develop a risk calculator for patients to predict and evaluate potential outcomes., Methods: A retrospective analysis was conducted on the medical records of patients with diabetic foot who visited a tertiary hospital in Vietnam between December 2021 and July 2022. Demographic data, clinical characteristics, and outcomes were collected and classified according to the WIfI (Wound, Ischemia, and foot Infection) classification system. Descriptive statistics were used to analyze the data, and a multivariable logistic regression model was employed to develop a risk calculator., Results: The study included 60 patients with diabetic foot. Gender distribution was similar (56.7% male), with a mean age of 44 years. Most patients had ulcers of varying degrees, while ischemia contributed to higher grades, placing 43.3% at moderate-to-high risk of amputation (stages 3 and 4). HbA1c positively correlated with amputation risk (p<0.05), while ABI, TBI, and TP showed inverse correlations (p<0.001). The amputation risk equation based on the WIfI scale was: risk=3.701-0.788ABI-1.260TP. A risk calculator was developed using these predictors to estimate adverse outcomes., Conclusion: In diabetic foot patients, early identification and management of risk factors are crucial. The findings of this study highlight the importance of ischemia and its association with amputation risk. Incorporating HbA1c, ABI, and TP, the risk calculator enables personalized assessments of amputation risk, thereby assisting healthcare professionals in treatment planning. Further validation and refinement of the risk calculator is required for broader clinical application., (Copyright © 2023 SEEN and SED. Published by Elsevier España, S.L.U. All rights reserved.)

Conventional classifications for diabetic foot, among them, Wagner Classification, do not contemplate the criteria or sichemia, neuropathy and infection, pillars that sustain the etiopathogy of this syndrome. With Modified Wagner Classification (MWC), there are cleary defined the phase and characteristics of the wound, incorporatin into the anatomical description by a graphical way (letters in capital letter or small one) the mentioned props (infection, neuropathy and ischemia). In this way not only the language is equal (comes to an agreement) to avoid interpretation mistakes, but also it is orientated by just one number and a letter towards a prognosis and treatment criteria. Cases received before and after the use of the MWC are compared perfoming a review, by two different professional groups, being catalogued by the same numbers in a high percentage. That is why we recommend its diffusion and generalized the employment for the managing of the diabetic foot.

Objective: Diabetic foot disease is a serious and common complication of diabetes mellitus. The aim of this study was to assess limb and patient factors associated with key clinical outcomes in diabetic patients with foot ulcers., Methods: This was a prospective observational study of diabetic patients with foot wounds admitted to a major tertiary teaching hospital in South Australia or seen at associated multidisciplinary foot clinics between February 2017 and December 2018. Patient demographic and clinical data were collected, including limb status severity assessed by the WIfI system and grip strength. Participants were followed up for 12 months. The primary outcomes were major amputation, death, amputation free survival, and completion of healing of the index wound within one year., Results: A total of 153 participants were recruited and outcome data were obtained for 152. Forty-two participants underwent revascularisation during the research period. Eighteen participants (11.8%) suffered major amputation of the index limb and 16 (10.5%) died during follow up. Complete wound healing was achieved in 106 (70%) participants. There was a statistically significant association between WIfI stage and major amputation (subdistribution hazard ratio [SHR] 2.75), mortality (hazard ratio [HR] 2.60), amputation free survival (odds ratio [OR] 0.32), and wound healing (SHR 0.69). There was also a statistically significant association between time to healing and grip strength (SHR 0.50), and previous amputations (major or minor) (SHR 0.57)., Conclusion: This prospective study supports the ability of the WIfI classification system to predict one year key clinical outcomes in a diabetic population with foot ulcers. It also demonstrated that grip strength may be a useful predictor of wound healing., (Copyright © 2021 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Objective: To compare the diagnostic accuracy of bone culture (microbiology) and biopsy (histology) in patients with acute or chronic diabetic foot osteomyelitis (DFO)., Methods: This cross-sectional study involved patients for whom providers had a clinical suspicion of DFO. Two bone samples were taken: one for microbiologic testing and another for histologic testing. The sensitivity, specificity, positive predictive value, negative predictive value, and likelihood ratio were calculated for bone culture results in relation to the probability of DFO diagnosis., Results: Fifty-two patients were included; 69% had positive bone culture results, and 90.4% had positive histology results (P = .013), and of those 90.4%, 25.5% had acute and 74.5% had chronic DFO. The sensitivity of the microbiologic bone culture result was 0.70, the specificity was 0.40, the positive predictive value was 0.92, and the negative predictive value was 0.13., Conclusions: Histology provides more accurate diagnosis of DFO than microbiology, especially for patients with chronic DFO. These patients could be underdiagnosed because of false-negative results provided by bone culture. Providers should perform both tests to confirm the presence of DFO., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: The frequent change in clinicians, and the emerging use of photographic documentation in wound management, could require a more diverse treatment of patients due to poor interobserver agreement. The aim of this study was to assess the interobserver agreement of a commonly used classification system for diabetic foot ulcers (DFUs), the Meggitt-Wagner classification, and to compare the agreement on classification with the agreement in treatment recommendations., Method: An interobserver study was conducted based on a questionnaire linked to 30 photographs of DFUs. Different groups of observers were tested to investigate whether there was a difference between professions or level of education: experienced orthopaedic wound care doctors (n=7); nurses specialised in wound care (n=8) and untrained nurses assigned to a diabetic wound care training course (n=23). Krippendorff's alpha was used to calculate interobserver agreement, and an agreement of >0.67 was defined as substantial., Results: The Krippendorff's alpha value for interobserver agreement on the Meggitt-Wagner classification was 0.52 for the doctors group, 0.67 for the specialised nurses and 0.61 for the untrained nurses. The corresponding values regarding agreement on recommendation of surgical revision of the wound were 0.35, 0.22 and 0.15, respectively. The choice of dressing type or antibiotic treatment had even lower interobserver agreement., Conclusions: The interobserver agreement on the Meggitt-Wagner classification was substantial in the specialised nurse group, but the evaluation and treatment of DFUs should not be exclusively based on pictorial materials.

Background: The need to classify, score and describe diabetic foot ulcerations is needed for accurate clinical documentation. An agreed wound classification can improve communication between health care professionals, and improve ease of discussion regarding potential outcomes. This study aimed to determine the inter-rater reliability between four validated wound classification systems., Research Design and Method: A prospective non-experimental comparative study was conducted. Forty patients with diabetes presenting with a new or long-standing ulceration were recruited. Each ulcer was graded/scored by three clinicians using four widely used classification systems; namely the University of Texas, SINBAD, Meggitt-Wagner and the PEDIS scoring systems., Results: All classifications had a satisfactory inter-rater agreement when evaluated by three raters of various clinical experience, however, the strength of the agreement varied between classifications. The Meggitt-Wagner system had an almost perfect agreement, the SINBAD and UT systems had a strong inter-rater agreement whilst the PEDIS had a moderate inter-rater agreement., Conclusion: Results of study serve as assurance and provides the evidence that these systems may be reliably used by different clinicians, even those with varied experience in wound care., (Copyright © 2020 Tissue Viability Society. Published by Elsevier Ltd. All rights reserved.)

Background: Diabetes-Related Foot Ulcers (DRFUs) are a common and devastating consequence of Diabetes Mellitus and are associated with high morbidity, mortality, social and economic costs. Whilst peak plantar pressures during gait are implicated cited as a major contributory factor, DRFU occurrence has also been associated with increased periods of sedentary behaviour. The present study was designed aimed to assess the effects of sitting postures on plantar tissue health., Methods: After a period of acclimatisation, transcutaneous oxygen tensions (T C PO 2 ) and inflammatory cytokines (IL-1α and IL-1RA) were measured at the dorsal and plantar aspects of the forefoot before, during and after a 20-min period of seated-weight-bearing in participants with diabetes (n = 11) and no diabetes (n = 10). Corresponding interface pressures at the plantar site were also measured., Results: During weight-bearing, participants with diabetes showed increases in tissue ischaemia which were linearly correlated proportional to plantar pressures (Pearson's r = 0.81; p < 0.05). Within the healthy group, no such correlation was evident (p > 0.05). There were also significant increases in post seated weight-bearing values for ratio for IL-1α and IL-1RA, normalised to total protein, post seated weight-bearing in participants with diabetes compared to healthy controls., Conclusion: This study shows that prolonged sitting may be detrimental to plantar skin health. It highlights the need to further examine the effects of prolonged sitting in individuals, who may have a reduced tolerance to loading in the plantar skin and soft tissues., (Crown Copyright © 2020. Published by Elsevier Ltd. All rights reserved.)

According to the World Health Organization (WHO), Diabetes Mellitus (DM) is one of the most prevalent diseases in the world. It is also associated with a high mortality index. Diabetic foot is one of its main complications, and it comprises the development of plantar ulcers that could result in an amputation. Several works report that thermography is useful to detect changes in the plantar temperature, which could give rise to a higher risk of ulceration. However, the plantar temperature distribution does not follow a particular pattern in diabetic patients, thereby making it difficult to measure the changes. Thus, there is an interest in improving the success of the analysis and classification methods that help to detect abnormal changes in the plantar temperature. All this leads to the use of computer-aided systems, such as those involved in artificial intelligence (AI), which operate with highly complex data structures. This paper compares machine learning-based techniques with Deep Learning (DL) structures. We tested common structures in the mode of transfer learning, including AlexNet and GoogleNet. Moreover, we designed a new DL-structure, which is trained from scratch and is able to reach higher values in terms of accuracy and other quality measures. The main goal of this work is to analyze the use of AI and DL for the classification of diabetic foot thermograms, highlighting their advantages and limitations. To the best of our knowledge, this is the first proposal of DL networks applied to the classification of diabetic foot thermograms. The experiments are conducted over thermograms of DM and control groups. After that, a multi-level classification is performed based on a previously reported thermal change index. The high accuracy obtained shows the usefulness of AI and DL as auxiliary tools to aid during the medical diagnosis.

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., (© 2020 John Wiley & Sons Ltd.)

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., (© 2020 John Wiley & Sons Ltd.)

The current Wagner and Texas classifications of diabetic foot ulcers (DFUs) are used worldwide to assess the extent of foot lesions, but wound treatment principles based on both the classification systems are lacking. We have summarized the STAGE principles of wound treatment for clinical practice based on the Wagner and Texas classification systems. The STAGE principles refer to the principles of surgical intervention during wound treatment of DFUs and emphasize that "based on anatomical layers, the management focuses on blood supply and includes layer-by-layer incision to the infected area, maintenance of effective wound drainage, and step-by-step treatment of the wound." During treatment, microcirculation improvement and microvascular angiogenesis (A) are essential for granulation tissue formation in the bone (skeleton, S) and tendons (T) and healing of the wound with reepithelialization (E). We defined the above mentioned steps as the STAGE principles, namely, layer-by-layer incision and step-by-step management (Phase A is essential for the treatments in Phases S-T and G-E). Ulcers or gangrene formed during Phases S-T or T should be treated according to the STAGE or TAGE principles, respectively. Similar treatment principles are applied in the other phases. However, treatments at each phase are not isolated and can be performed simultaneously. The STAGE principle can be combined with the tissue, infection, moisture, and wound edge (TIME) and TIME-H chronic wound treatment principles to eliminate the shortcomings of a single principle in wound management.

The aim of this study was to identify diabetic foot ulcer (DFU) patients at risk for the development of a hard-to-heal wound. This is a post-hoc analysis of a prospective cohort study including a total of 208 patients with a DFU. The primary endpoints were time to healing and the development of a hard-to-heal-wound. Univariable and multivariable logistic and Cox regression analysis were used to study the associations of patient characteristics with the primary endpoints. The number of previous DFUs [odds ratio (OR): 1.42, 95% confidence interval (CI): 1.01-1.99, P = .04], University of Texas (UT) classification grade 2 (OR: 2.93, 95% CI: 1.27-6.72, P = .01), UT classification grade 3 (OR: 2.80, 95% CI: 1.17-6.71, P = .02), and a diagnosis of foot stand deformation (OR: 1.54, 95% CI: 0.77-3.08, P = .05) were significantly associated with the development of a hard-to-heal wound. Only UT classification grade 3 (HR: 0.61, 95% CI: 0.41-0.90, P = .01) was associated with time to healing. The number of previous DFUs, UT classification grade, and a diagnosis of foot deformation are significantly associated with development of a hard-to-heal wound in patients with a DFU. The only predictor significantly associated with time to healing was UT classification grade 3. These patient characteristics can be used to identify patients at risk for the development of hard-to-heal wounds, who might need an early intervention to prevent wound problems., (© 2019 Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Objective: The aim of this study is to investigate the preexisting predictive factors associated with comorbidities for diabetic foot ulcer (DFU) in King classification III at an outpatient clinic., Method: This prospective study included 100 patients with DFU in King classification III treated at outpatient clinics in Chiayi Chang Gung Memorial Hospital from January 2011 to December 2011. The least follow-up time was 1 year. Medical documentations were in respect of patient's baseline characteristics, associated history, presence of comorbidities, follow-up time, and condition of wounds. Patients were divided into success group (healed or healing with wound reduction), stagnate group, and failure group (amputation or infection, need in-hospital medical service) in accordance with the treatment response of wounds. χ Test, Fisher exact test, and 1-way analysis of variance were used for variables in 3-group comparison, whereas Student t test was applied in 2-group comparison. The predictive factors with P value less than 0.1 were further investigated using the model of univariate logistic regression., Results: With 3-group stratification according to treatment response-failure (n = 8), stagnate (n = 22), and success (n = 70)-the occurrence rate of retinopathy was higher in the treatment stagnate group (42.1%) than in the treatment failure (14.3%) and success groups (12.5%; P = 0.019); the rate of previous percutaneous transluminal angioplasty (PTA) history was higher in the treatment failure group (25%) than in the treatment stagnate (4.8%) and success groups (1.5%; P = 0.020). With 2-group stratification-failure (n = 8) versus nonfailure (n = 92), and success (n = 70) versus nonsuccess (n = 30)-PTA history was strongly associated with treatment failure (odds ratio [OR], 14.33; 95% confidence interval [CI], 1.71-120.32; P = 0.014), whereas retinopathy (OR, 0.21; 95% CI, 0.07-0.65; P = 0.006) was the major negative predictor for treatment success. Previous debridement met borderline significance to predict treatment nonsuccess (OR, 0.09; 95% CI, 0.01-1.01; P = 0.051). Sex, age, associated history, dyslipidemia, hypertension, coronary artery disease, cerebrovascular accident, chronic kidney disease, and end-stage renal disease and wound condition had no statistical significance., Conclusions: Previous PTA and retinopathy, which indicated preexisting severe vasculopathy, are univariate predictive factors for treatment failure and nonsuccess, respectively, in patients with King classification III DFU. With the subdivision of King classification III DFU, medical history taking and fundus examination are acceptable methods for risk screening at an outpatient clinic.

Objective: To classify the level of risk for foot ulcers in people with diabetes mellitus and identify their main predictive risk factors., Method: Exploratory, descriptive study, in which patients were assessed in a municipal ambulatory of São Paulo through nursing consultation, following the guidelines of the International Consensus on the Diabetic Foot. Data were descriptively analyzed., Results: The analyzed population was composed of 50 longevous and retired people, with household income of up to two minimum wages, with dermato-neurofunctional risk factors and unfavorable clinical indicators, and 66% had Risk 1; 16% Risk 2; 6% Risk 3 and 12% Risk 4. Of this analyzed total, 96% never had their feet examined with the Semmes-Weinstein monofilament., Conclusion: The data found indicate the importance of careful feet examination in people with diabetes by the nursing staff to identify future risks of ulcers and, thus, prevent them.

Objective: Previous studies show conflicting results in wound healing outcomes based on angiosome direct perfusion (DP), but few have adjusted for wound characteristics in their analyses. We have previously shown that the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification correlates with wound healing in diabetic foot ulcers (DFUs) treated by a multidisciplinary team. The aim of this study was to compare WIfI classification vs DP and pedal arch patency as predictors of wound healing in patients presenting with DFU and peripheral arterial disease., Methods: We performed a retrospective review of a prospectively maintained database of all patients with peripheral arterial disease presenting to our multidisciplinary DFU clinic who underwent angiography. An angiosome was considered directly perfused if the artery feeding the angiosome was revascularized or was completely patent. Wound healing time at 1 year was compared on the basis of DP vs indirect perfusion, Rutherford pedal arch grade, and WIfI classification using univariable statistics and Cox proportional hazards models., Results: Angiography was performed on 225 wounds in 99 patients (mean age, 63.3 ± 1.2 years; 62.6% male; 53.5% black) during the entire study period. There were 33 WIfI stage 1, 33 stage 2, 51 stage 3, and 108 stage 4 wounds. DP was achieved in 154 wounds (68.4%) and indirect perfusion in 71 wounds (31.6%). On univariable analysis, WIfI classification was significantly associated with improved wound healing (57.2% for WIfI 3/4 vs 77.3% for WIfI 1/2; P = .02), whereas DP and pedal arch patency were not (both, P ≥ .08). After adjusting for baseline patient and wound characteristics, WIfI stage remained independently predictive of wound healing (WIfI 3/4: hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.67-0.88), whereas DP (HR, 0.82; 95% CI, 0.55-1.21) and pedal arch grade (HR, 0.85; 95% CI, 0.70-1.03) were not., Conclusions: In our population of patients treated by a multidisciplinary diabetic foot service, the Society for Vascular Surgery WIfI classification system was a stronger predictor of diabetic foot wound healing than DP or pedal arch patency. Our results suggest that a measure of wound severity should be included in all future studies assessing wound healing as an outcome, as differences in patients' wound characteristics may be a strong contributor to the variation of angiosome-directed perfusion results previously observed., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Diabetic foot ulcer is a common chronic complication of diabetes mellitus. In addition to conventional primary therapy, there are adjuvant therapy methods such as hyperbaric oxygen therapy for the healing of diabetic foot ulcer wounds. The present study aimed to determine the efficacy of hyperbaric oxygen therapy in diabetic foot ulcers based on Wagner classification. It was performed retrospectively from prospectively collected data. One hundred thirty patients with diabetic foot ulcers were assessed in 2 groups: 1 group received hyperbaric oxygen therapy; the other group did not. Patients were examined according to age, sex, ulcer grade based on Wagner classification; ulcer healing status; whether hyperbaric oxygen therapy was received; duration of diabetes in years; HbA1C, sedimentation, C-reactive protein levels; and presence of accompanying diseases, including peripheral arterial disease, chronic obstructive pulmonary disease, hypertension, chronic kidney disease, neuropathy, and retinopathy. The mean follow-up period was 19.5 ± 4.45 months (range 12 to 28 months). Seventy-one (54.6%) patients received hyperbaric oxygen therapy, and 59 (45.4%) patients did not. All patients in Wagner grade 2 healed in both groups. In the group that received hyperbaric oxygen therapy for grade 3 and 4 patients, 35 (87.5%) and 11 (84.6%) healed, respectively. In total, 60 (84.5%) patients in the group that received hyperbaric oxygen therapy healed. The subgroup comparison conducted according to Wagner classification revealed no differences between the 2 groups of grades 2 and 5 patients. It also revealed that treatment had higher levels of efficacy in the healing of ulcers in grade 3 and 4 patients., (Copyright © 2018. Published by Elsevier Inc.)

Plantar pressure is critical in the onset of neuropathic foot ulcers. However, risk classifications do not consider it as a stratification parameter. Whether plantar pressure distribution affects ulcer-risk was investigated. Patients from a research study (n. 134) and from a clinical environment (n. 83) were classified into ulcer-risk groups according to the International Working Group on the Diabetic Foot guidelines. Pressure distribution was acquired during gait (Pedar-X System), and assessed for hindfoot, midfoot, forefoot and toes (1way- and 2way-ANOVAs, p < 0.05). Pressure distribution changed with polyneuropathy even in the low-risk groups: median p = 0.048 (0.001-0.223). Risk classification correlated poorly with pressure distribution: median p = 0.686 (0.374-0.828). BMI, age and walking speed influenced most parameters and rendered the studies almost impossible to compare (2-way ANOVA factor A > 0.05). Pressure-time integral, the only comparable parameter between the two studies, may increase the predictive capacity of ulcer-risk stratification models.

Objective: Previous studies have reported correlation between the Wound, Ischemia, and foot Infection (WIfI) classification system and wound healing time on unadjusted analyses. However, in the only multivariable analysis to date, WIfI stage was not predictive of wound healing. Our aim was to examine the association between WIfI classification and wound healing after risk adjustment in patients with diabetic foot ulcers (DFUs) treated in a multidisciplinary setting., Methods: All patients presenting to our multidisciplinary DFU clinic from June 2012 to July 2017 were enrolled in a prospective database. A Cox proportional hazards model accounting for patients' sociodemographics, comorbidities, medication profiles, and wound characteristics was used to assess the association between WIfI classification and likelihood of wound healing at 1 year., Results: There were 310 DFU patients enrolled (mean age, 59.0 ± 0.7 years; 60.3% male; 60.0% black) with 709 wounds, including 32.4% WIfI stage 1, 19.9% stage 2, 25.2% stage 3, and 22.4% stage 4. Mean wound healing time increased with increasing WIfI stage (stage 1, 96.9 ± 8.3 days; stage 4, 195.1 ± 10.6 days; P < .001). Likelihood of wound healing at 1 year was 94.1% ± 2.0% for stage 1 wounds vs 67.4% ± 4.4% for stage 4 (P < .001). After risk adjustment, increasing WIfI stage was independently associated with poor wound healing (stage 4 vs stage 1: hazard ratio, [HR] 0.44; 95% confidence interval, 0.33-0.59). Peripheral artery disease (HR, 0.73), increasing wound area (HR, 0.99 per square centimeter), and longer time from wound onset to first assessment (HR, 0.97 per month) also decreased the likelihood of wound healing, whereas use of clopidogrel was protective (HR, 1.39; all, P ≤ .04). The top three predictors of poor wound healing were WIfI stage 4 (z score, -5.40), increasing wound area (z score, -3.14), and WIfI stage 3 (z score, -3.11), respectively., Conclusions: Among patients with DFU, the WIfI classification system predicts wound healing at 1 year in both crude and risk-adjusted analyses. This is the first study to validate the WIfI score as an independent predictor of wound healing using multivariable analysis., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose of Review: Diabetes mellitus affects approximately 30.8 million people currently living in the USA. Chronic diabetes complications, including diabetic foot complications, remain prevalent and challenging to treat. We review clinical diagnosis and challenges providers may encounter when managing diabetic foot ulcers and Charcot neuroarthropathy., Recent Findings: Mechanisms controlling these diseases are being elucidated and not fully understood. Offloading is paramount to heal and manage diabetic foot ulcers and Charcot neuroarthropathy. Diabetic foot ulcers recur and the importance of routine surveillance and multidisciplinary approach is essential. Several predictors of failure in Charcot foot include a related diabetic foot ulcer, midfoot or rearfoot location of the Charcot event, and progressive bony changes on interval radiographs. Patients with diabetic foot ulcer and/or Charcot neuroarthropathy are in need of consistent and regular special multidisciplinary care. If not diagnosed early and managed effectively, morbidity and mortality significantly increase.

Objective: We have previously demonstrated that the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification correlates with wound healing time in patients with diabetic foot ulcers (DFUs) treated in a multidisciplinary setting. Our aim was to assess whether the charges and costs associated with DFU care increase with higher WIfI stages., Methods: All patients presenting to our multidisciplinary diabetic limb preservation service from June 2012 to June 2016 were enrolled in a prospective database. Inpatient and outpatient charges, costs, and total revenue from initial visit until complete wound healing were compared for wounds stratified by WIfI classification., Results: A total of 319 wound episodes in 248 patients were captured, including 31% WIfI stage 1, 16% stage 2, 30% stage 3, and 24% stage 4 wounds. Limb salvage at 1 year was 95% ± 2%, and wound healing was achieved in 85% ± 2%. The mean number of overall inpatient admissions (stage 1, 2.07 ± 0.48 vs stage 4, 3.40 ± 0.27; P < .001), procedure-related admissions (stage 1, 1.86 ± 0.45 vs stage 4, 2.28 ± 0.24; P < .001), and inpatient vascular interventions (stage 1, 0.14 ± 0.10 vs stage 4, 0.80 ± 0.12; P < .001) increased significantly with increasing WIfI stage. There were no significant differences in mean number of inpatient podiatric interventions or outpatient procedures between groups (P ≥ .10). The total cost of care per wound episode increased progressively from stage 1 ($3995 ± $1047) to stage 4 ($50,546 ± $4887) wounds (P < .001). Inpatient costs were significantly higher for advanced stage wounds (stage 1, $21,296 ± $4445 vs stage 4, $54,513 ± $5001; P < .001), whereas outpatient procedure costs were not significantly different between groups (P = .72). Overall, hospital total revenue increased with increasing WIfI stage (stage 1, $4182 ± $1185 vs stage 4, $55,790 ± $5540; P < .002)., Conclusions: Increasing WIfI stage is associated with a prolonged wound healing time, a higher number of surgical procedures, and an increased cost of care. While limb salvage outcomes are excellent, the overall cost of DFU care from presentation to healing is substantial, especially for patients with advanced (WIfI stage 3/4) disease treated in a multidisciplinary setting., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Skin and soft tissue infections (SSTIs) involve a heterogeneous group of entities with different clinical presentations classified according to several specific criteria. Because of their great variability, their incidence and prevalence is difficult to accurately determine. Yet it is generally thought that the rate of SSTIs is globally increasing due to an aging population, strictly associated with the increase in the number of critical and immunocompromised patients. The aetiology of SSTIs is also extremely variable, reflecting the noteworthy heterogeneity of their clinical presentations and their epidemiology. Gram-positive are far more prevalently than Gram-negative cocci responsible for STTIs globally considered including both aerobe and anaerobe microorganisms. The emergence of multidrug-resistance bacteria represents a serious public health threat which is making antimicrobial therapy less efficacious and more challenging by the day.

Purpose: The purpose of this study was to investigate the effect of foot exercises on wound healing in type 2 diabetic patients with a diabetic foot ulcer., Design: Prospective, randomized controlled study., Subject and Settings: Sixty-five patients from an outpatient clinic with grade 1 or 2 ulcers (Wagner classification) who met study criteria agreed to participate; 60 patients completed the study and were included in the final analysis. Subjects were followed up between February 2014 and June 2015., Methods: Subjects were recruited by the researchers in the clinics where they received treatment. Subjects were randomly allocated to either the control or intervention group. Data were collected using investigator-developed forms: patient information form and the diabetic foot exercises log. Patients in the intervention group received standard wound care and performed daily foot exercises for 12 weeks; the control group received standard wound care but no exercises. The ulcers of the patients in both the intervention and control groups were examined and measured at the 4th, 8th, and 12th weeks. The groups were compared in terms of the ulcer size and depth. To analyze and compare the data, frequency distribution, mean (standard deviation), variance analysis, and the independent samples t test and the χ test were used., Results: The mean ulcer areas were 12.63 (14.43), 6.91 (5.44), 4.30 (3.70), and 3.29 (3.80) cm (P < .05) in the study intervention group, and 24.67 (20.70), 24.75 (20.84), 20.33 (20.79), and 18.52 (21.49) cm in the control group in the 4th, 8th, and 12th weeks, respectively. Significant differences were found between diabetic foot ulcer sizes in the study intervention group in the 4th and 12th weeks compared to beginning baseline (P ≤ .05). However, only the 12th week was different from the beginning in the control group (P = .000). The mean depths of the ulcers were 0.56 (0.85), 0.42 (0.68), 0.36 (0.50), and 0.28 (0.38) cm in the study intervention group (P < .05) and 0.61 (0.84), 0.82 (1.07), 0.83 (1.21), and 0.80 (1.26) cm in the control group, respectively, at the baseline, and at the 4th, 8th, and 12th weeks, respectively (P = .000)., Conclusion: The ulcer areas decreased significantly in the study intervention group compared to the control group during the 3 follow-up measurements. An important finding in this study was the DFU area decreased more in those who exercised more. Findings suggests foot exercises should be included in the treatment plan when managing patients with diabetic foot ulcers.

Background: The aim of this cohort study was to assess the inter-observer agreement of three diabetic foot classification systems: the Wagner, the University of Texas and the PEDIS., Methods: We included 250 consecutive patients diagnosed of diabetic foot syndrome in 2009-2013. Wound scores were recorded at admission and a reevaluation was performed simultaneously or 24h later by a different evaluator. Demographical, laboratory data and associated risk factors were obtained from the patients' medical records., Results: The Kappa coefficient showed a moderate inter-observer agreement between the first evaluation and the reevaluation for Wagner scale (Kappa=0.55; 95% CI: 0.507-0.593), University of Texas scale (Kappa=0.513; 95% CI: 0.463-0.563) and for PEDIS scale (Kappa=0.574; 95% CI: 0.522-0.626)., Conclusions: This moderate agreement shows that these scales should not be used alone for management decisions regarding diabetic foot syndrome and should, therefore, be integrated with other clinical data to ensure an adequate handover., (Copyright © 2016 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.)

Diabetes mellitus is a common metabolic disorder. Among various complications, diabetic neuropathy and peripheral vascular disorders are closely associated with diabetic foot ulcers (DFUs). Lower extremity ulcers and amputations are ongoing problems among individuals with diabetes. There are several classification systems for DFUs; however, no prognostic system has to date been accepted as the gold standard or the optimum prediction tool for amputations. A retrospective study was designed. Demographic data and baseline laboratory data were gathered and scored or evaluated using five representative DFU classification systems. These included (i) the diabetic ulcer severity score (DUSS); (ii) University of Texas (UT) diabetic wound classification; (iii) Meggitt-Wagner classification; (iv) depth of the ulcer, extent of bacterial colonisation, phase of ulcer and association aetiology (DEPA) scoring system; and (v) site, ischaemia, neuropathy, bacterial infection and depth (SINBAD) score. Finally, a statistical analysis was performed. A total of 137 patients were included in this study. During the follow-up, DFU had healed in 51·1% of subjects and 48·9% of the individuals underwent lower extremity amputations (LEAs). In a univariable logistic regression analysis, history of previous DFU, hypertension, neuropathy, haemoglobin, C-reactive protein (CRP) and ankle-brachial index (ABI) showed a statistically significant difference between the healed group and the LEA group. Moreover, the stages, grades or overall prognostic ability of all five classifications were highly associated with the overall occurrence of LEA. On multivariable logistic regression analysis of the risk of LEA, all classifications showed a significant positive trend with an increased number of amputations. All the five classification systems exhibited high sensitivity, specificity, classification accuracy, positive predictive, negative predictive and area under the curve (AUC) values. They showed substantial accuracy and their main variables were associated with LEA occurrence. The Wagner and UT systems, although they are relatively simple to assess, were better predictors of LEA., (© 2016 Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Objective: The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) threatened limb classification has been shown to correlate well with risk of major amputation and time to wound healing in heterogeneous diabetic and nondiabetic populations. Major amputation continues to plague the most severe stage 4 WIfI patients, with 1-year amputation rates of 20% to 64%. Our aim was to determine the association between WIfI stage and wound healing and major amputation among patients with diabetic foot ulcers (DFUs) treated in a multidisciplinary setting., Methods: All patients presenting to our multidisciplinary DFU clinic from July 2012 to December 2015 were enrolled in a prospective database. Wound healing and major amputation were compared for patients stratified by WIfI classification., Results: There were 217 DFU patients with 439 wounds (mean age, 58.3 ± 0.8 years; 58% male, 63% black) enrolled, including 28% WIfI stage 1, 11% stage 2, 33% stage 3, and 28% stage 4. Peripheral arterial disease and dialysis were more common in patients with advanced (stage 3 or 4) wounds (P ≤ .05). Demographics of the patients, socioeconomic status, and comorbidities were otherwise similar between groups. There was a significant increase in the number of active wounds per limb at presentation with increasing WIfI stage (stage 1, 1.1 ± 0.1; stage 4, 1.4 ± 0.1; P = .03). Mean wound area (stage 1, 2.6 ± 0.6 cm 2 ; stage 4, 15.3 ± 2.8 cm 2 ) and depth (stage 1, 0.2 ± 0.0 cm; stage 4, 0.8 ± 0.1 cm) also increased progressively with increasing wound stage (P < .001). Minor amputations (stage 1, 18%; stage 4, 56%) and revascularizations (stage 1, 6%; stage 4, 55%) were more common with increasing WIfI stage (P < .001). On Kaplan-Meier analysis, WIfI classification was predictive of wound healing (P < .001) but not of major amputation (P = .99). For stage 4 wounds, the mean wound healing time was 190 ± 17 days, and risk of major amputation at 1 year was 5.7% ± 3.2%., Conclusions: Among patients with DFU, the WIfI classification system correlated well with wound healing but was not associated with risk of major amputation at 1 year. Although further prospective research is warranted, our results suggest that use of a multidisciplinary approach for DFUs may augment healing time and reduce amputation risk compared with previously published historical controls of standard wound care among patients with advanced stage 4 disease., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Aims: To prospectively validate the existing classifications to stratify subjects with diabetes mellitus (DM) by their risk of diabetic foot ulcer (DFU), in high and low risk settings., Methods: A prospective multicentre cohort study was conducted, including 446 subjects with DM without active DFU followed in the hospital or primary care setting. Demographic, clinical characterization variables, and those included in the classifications were collected at baseline. Subjects were followed for 1year, until DFU or death., Results: In our sample, with a mean age of 65years, 52% were male; 32 developed a DFU, 7 required an amputation and 18 died. Differences were found between participants' characteristics and classifications' accuracy according to the setting. The great majority of the variables were associated with higher DFU risk. Globally, classifications were highly and equally valid, positive predictive values (PV) were inferior to 40%, negative PV superior to 90% and area under the receiver operating characteristic curve superior to 0.75., Discussion: All the existing classifications are valid to be applied in high risk clinical context and have a very high capacity to categorize as low risk those subjects that will not develop a DFU. Further research is needed in the primary care setting., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Purpose: The purpose of this article was to evaluate the accuracy of 2 physical activity monitors, monitors 1 and 2, for measuring weight-bearing activity in persons with prior diabetic foot ulcers., Design: Cross-sectional design., Instruments: Two recently developed monitors were used to differentiate anatomical postures such as lying, sitting, and standing upright. One monitor was designed to distinguish between duration of standing and walking and the other combines duration of standing and walking into 1 measure., Subjects and Setting: Thirty-one subjects were recruited; all participants had experienced a diabetic foot ulcer and completed participation in a previous cohort study. The study setting was 2 medical centers in the Midwestern United States., Methods: Subjects simultaneously wore the 2 monitors while performing 14 weight-bearing (ie, walking and standing) and non-weight-bearing (ie, sitting and lying) activities. The duration spent on each activity and the total number of steps taken for each walking activity were directly observed and recorded with each monitor. The accuracy of monitors 1 and 2 was assessed via direct observation as a reference standard. Paired-samples t tests were used to examine the difference in accuracy between the 2 monitors., Results: For measuring duration of activity, the accuracy of monitor 1 ranged from 73% to 100% for walking, 50% for standing, and from 42% to 100% for sitting/lying. In contrast, the accuracy of monitor 2 ranged from 98% to 100% for walking, 100% for standing, and from 97% to 100% for sitting/lying. The accuracy of monitor 1 for counting the number of steps ranged from 43% to 81%, while the accuracy of monitor 2 ranged from 91% to 99%. Monitor 2 was significantly more accurate than monitor 1 in measuring duration of standing still, slow walking, pedaling while sitting, lying on the left, and lying on the right, as well as measuring steps across different kinds of walking activities. Differences in monitor accuracy between subjects with and without foot pain and between subjects with and without foot amputation were not statistically significant., Conclusion: These findings suggest that monitor 2 is a more accurate measure of weight-bearing activities than monitor 1 among patients with previous diabetic foot ulcers. Additionally, the 2 monitors differ in terms of function; monitor 2 distinguishes standing from walking, whereas monitor 1 combines standing and walking into 1 measure. We recommend monitor 2 to examine the impact of weight-bearing activity on foot ulceration in patients with diabetic neuropathy.

Patients with peripheral neuropathy associated with ulceration are the nemesis of the orthopedic foot and ankle surgeon. Diabetic foot syndrome is the leading cause of peripheral neuropathy, and its prevalence continues to increase at an alarming rate. Poor wound healing, nonunion, infection, and risk of amputation contribute to the understandable caution toward this patient group. Significant metalwork is required to hold these technically challenging deformities. Neuropathic Minimally Invasive Surgeries is an addition to the toolbox of management of the diabetic foot. It may potentially reduce the risk associated with large wounds and bony correction in this patient group., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Neuropathic changes in the foot are common with a prevalence of approximately 1%. The diagnosis of neuropathic arthropathy is often delayed in diabetic patients with harmful consequences including amputation. The appropriate diagnosis and treatment can avoid an extensive programme of treatment with significant morbidity for the patient, high costs and delayed surgery. The pathogenesis of a Charcot foot involves repetitive micro-trauma in a foot with impaired sensation and neurovascular changes caused by pathological innervation of the blood vessels. In most cases, changes are due to a combination of both pathophysiological factors. The Charcot foot is triggered by a combination of mechanical, vascular and biological factors which can lead to late diagnosis and incorrect treatment and eventually to destruction of the foot. This review aims to raise awareness of the diagnosis of the Charcot foot (diabetic neuropathic osteoarthropathy and the differential diagnosis, erysipelas, peripheral arterial occlusive disease) and describe the ways in which the diagnosis may be made. The clinical diagnostic pathways based on different classifications are presented. Cite this article: Bone Joint J 2016;98-B:1155-9., (©2016 The British Editorial Society of Bone & Joint Surgery.)

Aims: The concept of 'classification' has, similar to many other diseases, been found to be fundamental in the field of diabetic medicine. In the current study, we aimed at determining efficacy measures of a recently published plantar pressure based classification system., Methods: Technical efficacy of the classification system was investigated by applying a high resolution, pixel-level analysis on the normalized plantar pressure pedobarographic fields of the original experimental dataset consisting of 97 patients with diabetes and 33 persons without diabetes. Clinical efficacy was assessed by considering the occurence of foot ulcers at the plantar aspect of the forefoot in this dataset. Classification efficacy was assessed by determining the classification recognition rate as well as its sensitivity and specificity using cross-validation subsets of the experimental dataset together with a novel cohort of 12 patients with diabetes., Results: Pixel-level comparison of the four groups associated to the classification system highlighted distinct regional differences. Retrospective analysis showed the occurence of eleven foot ulcers in the experimental dataset since their gait analysis. Eight out of the eleven ulcers developed in a region of the foot which had the highest forces. Overall classification recognition rate exceeded 90% for all cross-validation subsets. Sensitivity and specificity of the four groups associated to the classification system exceeded respectively the 0.7 and 0.8 level in all cross-validation subsets., Conclusions: The results of the current study support the use of the novel plantar pressure based classification system in diabetic foot medicine. It may particularly serve in communication, diagnosis and clinical decision making., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Scoring systems for diabetic foot ulcers may be used for clinical purposes, research or audit, to help assess disease severity, plan management, and even predict outcomes. While many have been validated in study populations, little is known about their interobserver reliability. This prospective study aimed to evaluate interobserver reliability of 3 scoring systems for diabetic foot ulceration. After sharp debridement, diabetic foot ulcers were classified by a multidisciplinary pool of trained observers, using the PEDIS (Perfusion, Extent, Depth, Infection, Sensation), SINBAD (Site, Ischemia, Neuropathy, Bacterial infection, Depth), and University of Texas (UT) wound classification systems. Interobserver reliability was assessed using intraclass correlations (0 = no agreement; 1 = complete agreement). Thirty-seven patients (78.4% male) were assessed by a pool of 12 observers. Single observer reliability was slight to moderate for all scoring systems (UT 0.53; SINBAD 0.44; PEDIS 0.23-0.42), but multiple observer reliability was almost perfect (UT 0.94; SINBAD 0.91; PEDIS 0.80-0.90). The worst agreement for single observers was when scoring infection (SINBAD 0.28; PEDIS 0.28), ischemia (SINBAD 0.26; PEDIS 0.23), or both (UT 0.25); however, this improved to almost perfect agreement for multiple observers (infection: 0.83; ischemia: 0.80-0.82; both: 0.81). These classification systems may be reliably used by multiple observers, for example, when conducting research and audit. However, they demonstrate only slight to moderate reliability when used by a single observer on an individual subject and may therefore be less helpful in the clinical setting, when documenting ulcer characteristics or communicating between colleagues., (© The Author(s) 2016.)

We obtained costs and mortality data in two retrospective cohorts totaling 159 patients who have diabetes mellitus and onset of a diabetic foot ulcer (DFU). Data were collected from 2005 to 2013, with a follow-up period through September 30, 2014. A total of 106 patients entered an evidence-based limb salvage protocol (LSP) for Wagner Grade 3 or 4 (WG3/4) DFU and intention-to-treat adjunctive hyperbaric oxygen (HBO₂) therapy. A second cohort of 53 patients had a primary lower extremity amputation (LEA), either below the knee (BKA) or above the knee (AKA) and were not part of the LSP. Ninety-six of 106 patients completed the LSP/HBO₂with an average cost of USD $33,100. Eighty-eight of 96 patients (91.7%) who completed the LSP/HBO₂had intact lower extremities at one year. Thirty-four of the 96 patients (35.4%) died during the follow-up period. Costs for a historical cohort of 53 patients having a primary major LEA range from USD $66,300 to USD $73,000. Twenty-five of the 53 patients (47.2%) died. The difference in cost of care and mortality between an LSP with adjunctive HBO₂therapy vs. primary LEA is staggering. We conclude that an aggressive limb salvage program that includes HBO₂ therapy is cost-effective.

Patients with diabetes mellitus (DM) are at risk of development of both diabetic foot syndrome and ulcers on the lower legs due to chronic venous insufficiency and other factors. The main group in this study was comprised of diabetic patients with ulcers of different etiology (venous, post-traumatic, mixed) treated at the Diabetic Foot Cabinet during 5 years (n=101). The group of comparison included simultaneously treated patients with diabetic foot syndrome (n=721). Patients of the main group was dominated by women (71%) and patients with type 2 DM. Ulcer healing due to the treatment, persistent non-healing ulcers, and high-level amputations occurred equally often in the two groups: 60 and 58%, 18 and 15%, 4 and 5% respectively (р>0,05). Lower leg ulcers in DM are very persistent and constitute a serious medico-social problem to be addresses based at Diabetic Foot cabinets. The frequency of such ulcers and related amputations must be taken into consideration in epidemiological surveys.

Introduction: One of the most serious complications of the diabetic foot (DF) is a major amputation, which is associated with poor patient prognosis. The occurrence of major amputations may be influenced by a variety of factors including deep infection caused by resistant pathogens.The aims of our study were to compare the incidence of major amputations in podiatric center, characteristics of amputated patients with the DF and other factors contributing to major amputations in last decade., Methods: We included into our study all patients hospitalized for the DF in our center whose underwent major amputations from 9/2004 to 9/2006 (group 1) and from 9/2013 to 9/2015 (group 2). Risk factors such as severity of DF ulcers based on Texas classification, duration of previous anti-biotic therapy, the presence and severity of peripheral arterial disease (PAD) according to Graziani classification, the number of revascularizations, renal failure/hemodialysis, osteomyelitis, infectious agents found before amputations and their resistance were compared between the study groups., Results: During the 1st study period (9/2004-9/2006) 373 patients were hospitalized for the DF, of whom 3.2 % underwent major amputation (12/373 - group 1), during the 2nd study period (9/2013-9/2015) 376 patients, of whom 5.1 % absolved major amputation (19/376 - group 2). As the numbers of major amputations as their indications were similar in both study groups. The study groups did not differ significantly in the age, BMI, duration and type of diabetes, duration of DF and severity of DF ulcers, the presence of renal failure/hemodialysis, osteomyelitis and PAD. Group 2 had milder forms of PAD by Graziani classification (4.4 ±1.4 vs 5.7 ± 0.9; p = 0.012) and a higher number of revascularizations before major amputations (2.5 ± 1.5 vs 1 ± 1; p = 0.003) compared to the group 1. These patients were significantly longer treated by antibiotics (5.4 ± 2.4 vs 2.5 ± 2 months; p = 0.002) and underwent more resections and minor amputations (3.1 ± 2.1 vs 0.9 ± 0.5; p = 0.0004) before major amputations in contrast to the group 1. There was a trend to higher incidence of Gram-negatives (65.1 % vs 61.5 %; NS) with a predominance of Enterobacteriacae species (60.7 % vs 56 %; NS) and a trend to the increase of Pseudomonas (25 % vs 18.8 %; NS) and Enterococci sp. (46.7 % vs 20 %; NS) in the group 2 compared to the group 1. The incidences as of MRSA, multidrug resistant Pseudomonas sp. of other resistant microbes were similar in both study groups., Conclusions: The incidence of major amputations in patients hospitalized for the DF remains unchanged during the last decade. The therapy of factors leading to amputations has evidently intensified. This is in accordance with the latest international recommendations for the therapy of DF. In the future, it is appropriate to focus on the improvement of detection and treatment of infection and ischemia in such risk group of patients.Key words: diabetic foot - major amputation.

Aim: To study toe ulcer healing in patients with diabetic foot ulcers attending a multidisciplinary foot clinic over a 10 years period., Methods: The study was retrospective, consecutive and observational during 2001 through 2011. The patients were treated according to the International Consensus on the Diabetic Foot. During the period the chiropodist staffing in the foot clinic was doubled; new offloading material and orthopedic foot corrections for recalcitrant ulcers were introduced. Healing was investigated in toe ulcers in Cox regression models., Results: 2634 patients developed foot ulcers, of which 1461 developed toe ulcers; in 790 patients these were neuropathic, in 551 they were neuro-ischemic and in 120 they were critically ischemic. One-year healing rates increased in the period 2001-2011 from 75% to 91% for neuropathic toe ulcers and from 72% to 80% for neuro-ischemic toe ulcers, while no changes was observed for ischemic toe ulcers. Adjusted for changes in the patient population, the overall rate of healing for neuropathic and neuro-ischemic toe ulcers almost doubled (HR=1.95 [95% CI: 1.36-2.80])., Conclusion: The results show that the healing of toe ulcers improved. This outcome could not be explained by changes in the patient characteristics, but coincided with a number of improvements in organization and therapy., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Background: This study aimed to validate and compare the existing systems developed to stratify subjects with diabetic foot ulcers by risk of consequent lower extremity amputation., Methods: We conducted a prospective cohort study on a consecutive series of patients (mean age of 68 years; 64% male) with active ulcer who were attending our Hospital Diabetic Foot Clinic (n = 293) from January 2010 to March 2013. At baseline, we collected information on the participants' characteristics and the relevant variables. Afterwards, we assessed the predictive value of each variable and each system's prognostic accuracy for amputation occurrence., Results: During a median follow-up of 91 days (interquartile range of 98), ulcers healed in 62% of the subjects. Major amputation occurred in 7% and minor occurred in 17%. Previous ulcer or amputation, ulcer area, and gangrene were associated with amputation occurrence. Nephropathy, pulses number, ulcer aetiology, depth, and number were associated with risk of amputation. Systems typically presented sensitivity values ≥80% and negative likelihood ratios ≤0.5 for the highest risk group; area under the receiver operating characteristic curve ranged from 0.56 to 0.83 and positive likelihood ratios from 1.0 to 5.9. If one chose only major amputation as an outcome, positive predictive values were lower, and negative predictive values tended to be higher., Conclusions: System stages, grades, scores, and/or prognostics were generally associated with amputation, presenting overall substantial accuracy values. Nevertheless, great improvement is possible. A multicentre study validating and refining the existing systems is needed to improve clinical decision-making in this area., (Copyright © 2014 John Wiley & Sons, Ltd.)

Background: The role of hyperbaric oxygen (HBO2) for the treatment of diabetic foot ulcers (DFUs) has been examined in the medical literature for decades. There are more systematic reviews of the HBO2/DFU literature than there have been randomized controlled trials (RCTs), but none of these reviews has resulted in a clinical practice guideline (CPG) that clinicians, patients and policy-makers can use to guide decision-making in everyday practice., Methods: The Undersea and Hyperbaric Medical Society (UHMS), following the methodology of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group, undertook this systematic review of the HBO2 literature in order to rate the quality of evidence and generate practice recommendations for the treatment of DFUs. We selected four clinical questions for review regarding the role of HBO2 in the treatment of DFUs and analyzed the literature using patient populations based on Wagner wound classification and age of the wound (i.e., acute post-operative wound vs. non-healing wound of 30 or more days). Major amputation and incomplete healing were selected as critical outcomes of interest., Results: This analysis showed that HBO2 is beneficial in preventing amputation and promoting complete healing in patients with Wagner Grade 3 or greater DFUs who have just undergone surgical debridement of the foot as well as in patients with Wagner Grade 3 or greater DFUs that have shown no significant improvement after 30 or more days of treatment. In patients with Wagner Grade 2 or lower DFUs, there was inadequate evidence to justify the use of HBO2 as an adjunctive treatment., Conclusions: Clinicians, patients, and policy-makers should engage in shared decision-making and consider HBO2 as an adjunctive treatment of DFUs that fit the criteria outlined in this guideline. The current body of evidence provides a moderate level of evidence supporting the use of HBO2 for DFUs. Future research should be directed at improving methods for patient selection, testing various treatment protocols and improving our confidence in the existing estimates.

Aims: To validate the perfusion, extent, depth, infection and sensation (PEDIS) classification system and to make the clinical practice easier, we created a score system and compared this system with two previously published common score systems., Methods: A retrospective cohort study was conducted on patients with diabetic foot ulcer (DFU) attending our hospital (n=364) from May 2007 to September 2013. Participants' characteristics and all variables composing the PEDIS classification system were assessed., Results: During a median follow-up of 25 months (range 6-82), ulcers healed in 217 of the 364 patients (59.6%), remained unhealed in 37 patients (10.2%), and were resolved by amputation in 62 patients (17.0%); 48 patients (13.2%) died. When measured using the PEDIS classification system, the outcome of DFU deteriorated with increasing severity of each subcategory. Additionally, longer ulcer history, worse perfusion of lower limb, a larger extent of the ulcer, a deeper wound, more severe infection, and loss of protective sensation were independent predictors of adverse outcome. More importantly, the new PEDIS score system showed good diagnostic accuracy, especially when compared with the SINBAD and Wagner score systems., Conclusions: The PEDIS classification system, which encompasses relevant variables that contribute to the outcome of DFU and has excellent capacity for predicting the ulcer outcome, demonstrated acceptable accuracy. The PEDIS classification system might be useful in clinical practice and research both for the anticipation of health care costs and for comparing patient subgroups.