Statins may be associated with six‐week diabetic foot ulcer healing

Diabetic foot ulcers (DFUs) affect 1.5 million Americans annually, of which only a minority heal with standard care, and they commonly lead to amputation. To improve care, investigations are underway to better understand DFU pathogenesis and develop more effective therapies. Some currently used medications may improve healing. One small, randomized clinical trial found statins improve DFU healing. In this secondary analysis of a large multisite prospective observational cohort of 139 patients with DFUs receiving standard care, we investigated whether there was an association between 6‐week DFU wound size reduction and use of a variety of medications including alpha‐blockers, beta‐blockers, angiotensin converting enzyme inhibitors (ACEi) and statins. We found no significant (p < 0.05) association between six‐week wound reduction and use of any of the evaluated drugs; however, statins did trend toward an association (p = 0.057). This suggests a potential benefit of statins on DFU healing, and larger, targeted studies are warranted.     

Outcome predictors for wound healing in patients with a diabetic foot ulcer

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.     

Relationship between items of DMIST and healing of diabetic foot ulcers

A monitoring tool for the wound-healing process of diabetic foot ulcers (DFUs) was developed. It comprises seven domains, namely, depth, maceration, inflammation/infection, size, tissue type of the wound bed, type of wound edge, and tunnelling/undermining. It was named “DMIST” based on the initials of its domains. Although DMIST is useful for assessing wound-healing processes, the monitoring items related to wound healing remain unclear, thereby making the selection of optimal care based on the assessment difficult. We identified the relationship between the DMIST items and wound healing. This study was a secondary analysis of five previous investigations and was conducted using DMIST based on the diabetic foot ulcer assessment scale score and DFU images. Multivariate logistic regression was used to calculate odds ratios (ORs) and 95% confidence intervals (95% CIs) after simultaneously controlling for potential confounders. The examined DFU healing status revealed that some DFUs healed at 4 weeks from baseline, whereas some DFUs did not. Variables considered in the models were the scores of each DMIST domain. The study population comprised 146 Indonesian patients and 33 Japanese patients. Depth, maceration, and size were associated with DFU healing at 4 weeks from baseline [depth: OR = 0.317 (95% CI: 0.145-0.693, P = 0.004); maceration: OR = 0.445 (95% CI: 0.221-0.896, P = 0.023); size: OR = 0.623 (95% CI: 0.451-0.862, P = 0.004)]. Our findings suggest that appropriate management of maceration promotes DFU healing.     

High‐dose folic acid and its effect on early stage diabetic foot ulcer wound healing

High‐dose folic acid (HDFA; vitamin B9)—5 mg, given daily, has not been evaluated as a treatment to improve early stage‐diabetic foot ulcer (ES‐DFU) wound healing. However, HDFA has been demonstrated to correct: (a) endothelial dysfunction and decreased nitric oxide (NO) bioavailability, associated with type‐2 diabetes mellitus (T2DM); and (b) hyperhomocysteinemia (HHcy) that may promote impaired DFU‐wound healing. Measures of wound area (cm²) reduction (wound closure; WC), over a 4‐week period (4 W‐WC), greater than 50% of the wound area, have been reported as a robust indicator of the potential for DFU‐wound healing. By using this model, we examined the effectiveness of a wound treatment in promoting progressive healing and complete wound closure for the chronic, nonhealing DFU‐wound. To investigate this possible relationship between HDFA and ES‐DFU wound healing, a retrospective cohort study of medical records, between November 2018 and April 2019, was performed for Veterans with T2DM and ES‐DFUs following treatment with HDFA. During the study period 29 (n = 29) Veterans with ES‐DFU wounds who received HDFA treatment were identified. Medical record reviews of this retrospective cohort of ES‐DFU Veterans receiving HDFA report 90% (26/29) experiencing complete DFU‐wound closure during the study period. Of the 29 Veterans with ES‐DFUs receiving HDFA, the medical records of nine (30%), with healed wounds, provided documentation suitable for 4 W‐WC, pre‐ and post‐HDFA treatment study comparisons. This study documents significant (P < .05) improvements comparing 4 W‐WC values for standard treatment for Veterans with poorly progressing, worsening or stagnating ES‐DFU‐wounds to those for the same subjects following HDFA treatment. These observations suggest that chronic ES‐DFUs treated with HDFA may experience significantly improved wound closure and complete healing (re‐epithelialization) when compared with standard treatments without HDFA. With validation from RCTs, HDFA may be established as an effective treatment to promote wound healing and closure for nonhealing ES‐DFUs.     

Use of an aseptically processed,dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective,randomised, multi‐centre clinical trial in 80 patients

Amnion and chorion allografts have shown great promise in healing diabetic foot ulcers (DFUs). Results from an interim analysis of 40 patients have demonstrated the accelerated healing ability of a novel aseptically processed, dehydrated human amnion and chorion allograft (dHACA). The goal of this study was to report on the full trial results of 80 patients where dHACA was compared with standard of care (SOC) in achieving wound closure in non‐healing DFUs. After a 2‐week screening period, during which patients with DFUs were unsuccessfully treated with SOC, patients were randomised to either SOC alone or SOC with dHACA applied weekly for up to 12 weeks. At 12 weeks, 85% (34/40) of the dHACA‐treated DFUs healed, compared with 33% (13/40) treated with SOC alone. Mean time to heal within 12 weeks was significantly faster for the dHACA‐ treated group compared with SOC, 37 days vs 67 days in the SOC group (P = .000006). Mean number of grafts used per healed wound during the same time period was 4.0, and mean cost of the tissue to heal a DFU was $1771. The authors concluded that aseptically processed dHACA heals DFUs significantly faster than SOC at 12 weeks.     

Quality of life in patients with diabetic foot ulcers: validation of the Cardiff Wound Impact Schedule in a Canadian population

The purpose of this study was to evaluate and validate the Cardiff Wound Impact Schedule (CWIS), a disease‐specific quality‐of‐life measure, in a diabetic foot ulcer (DFU) population. Patients with DFUs have restrictions as part of their treatment and rehabilitation, which can affect health‐related quality of life (HRQoL). Because of the high number of comorbidities experienced in diabetes, a disease‐specific quality‐of‐life measure is needed to best assess the affect of a foot ulcer on HRQoL. Patients with DFUs completed the CWIS and a World Health Organization generic quality‐of‐life questionnaire. Validity was assessed by comparing domains of the questionnaires. Patients were categorised using the University of Texas wound classification system. Mean CWIS scores were compared between categories to assess the questionnaire's ability to differentiate wound severity. Patients with open ulcers scored significantly lower on the CWIS than those with healed ulcers. Correlations between questionnaire domains were as follows: Social Life with Social Functioning (r = 0·641, P < 0·001); Well‐Being with General Health (r = 0·533, P < 0·01); Physical Symptoms and Daily Living with Physical Functioning (r = 0·631, P < 0·01) and Health‐Related Quality of Life with Vitality (r = 0·425, P < 0·01). However, there was no significant difference in mean CWIS scores between categories of wound severity. We have demonstrated the ability of the CWIS in assessing HRQoL in a DFU population and its ability to differentiate between healed and non healed states.     

A prospective,randomised, controlled,multicentre clinical trial examining healing rates,safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers

Acellular dermal matrices can successfully heal wounds. This study's goal was to compare clinical outcomes of a novel, open‐structure human reticular acellular dermis matrix (HR‐ADM) to facilitate wound closure in non‐healing diabetic foot ulcers (DFUs) versus DFUs treated with standard of care (SOC). Following a 2‐week screening period in which DFUs were treated with offloading and moist wound care, patients were randomised to either SOC alone or HR‐ADM plus SOC applied weekly for up to 12 weeks. At 6 weeks, the primary outcome time, 65% of the HR‐ADM‐treated DFUs healed (13/20) compared with 5% (1/20) of DFUs that received SOC alone. At 12 weeks, the proportions of DFUs healed were 80% and 20%, respectively. Mean time to heal within 12 weeks was 40 days for the HR‐ADM group compared with 77 days for the SOC group. There was no incidence of increased adverse or serious adverse events between groups or any adverse events related to the graft. Mean and median graft costs to closure per healed wound in the HR‐ADM group were $1475 and $963, respectively. Weekly application of HR‐ADM is an effective intervention for promoting closure of non‐healing DFUs.     

Diabetic foot ulcer,the effect of resource‐poor environments on healing time and direct cost: A cohort study during Syrian crisis

Diabetic foot ulcer (DFU) is one of the slowest healing wounds that hurt the human body. Many studies from developed countries are concerned about materials, procedures, and equipment that accelerate the healing time. In Sweden, the diabetic foot management costs around 24965$/patient. In this review, we would evaluate the healing time of DFUs during what is considered one of the worst humanitarian crisis of the 21st century. 1747 DFUs were studied from the main diabetic foot clinic in Damascus (2014‐2019). We predicted many variables that could prolong the healing time. The cost according to these variables was also reported. The SINBAD Classification was performed to grade the severity of ulcers. We noticed that the median healing time for DFUs was 8 weeks. Almost half of these ulcers healed between 3 and 12 weeks. The time of healing for men was significantly longer than that for women. While the presence of infection doubled the median time of healing, the presence of peripheral artery disease doubled the mean of the direct health care cost. The location of the ulcer acted as another independent risk factor. In conclusion, DFUs face many barriers to heal during a crisis.The environment with resource‐poor settings should be added to the traditional risk factors that delay the healing of DFUs for months or even years. More studies from disaster are as are needed to evaluate low‐cost materials that could be cost effective in applying standard care of the diabetic foot.     

Use of hyperspectral imaging to predict healing of diabetic foot ulceration

Our main objective was to validate that hyperspectral imaging via a new portable camera carries the potential to provide a reliable clinical biomarker that can predict DFU healing. We recruited patients with diabetic foot ulceration (DFU) without peripheral arterial disease, infection or other serious illness. Using an hyperspectral imaging (HSI) apparatus, post-debridement hyperspectral images were taken evaluating the ulcer size, periwound oxyhemoglobin (OxyHb), deoxyhemoglobin level (DeoxyHb) and oxygen saturation (O₂Sat) for four consecutive visits. Twenty-seven patients were followed, out of whom seven healed their DFU while the remaining 20 failed to heal their DFU. The average time between each visit was 3 weeks. Binary logistic regression of healers versus non-healers on Visit 1 oxyHb and on Visit 2 showed a significant inverse association, OR = 0.85 (95% CI: 0.73–0.98, p < 0.001). An inverse correlation was observed between the Visit 1 oxyHb and the percentage of ulcer size reduction between Visit 1 and Visit 4 (r = −0.46, p = 0.02) and between the Visit 2 oxyHb and the percentage of ulcer size reduction between Visits 2 and 4 (r = −0.65, p = 0.001). Using oxyHb 50 as the cut-off point to predict DFU complete healing, Visit 1 oxyHb measurement provided 85% sensitivity, 70% specificity, 50% positive predictive value and 93% negative predictive value. For Visit 2, oxyHb had 85% sensitivity, 85% specificity, 66% positive predictive value and 94% negative predictive value. We conclude that this preliminary study, which involved a relatively small number of patients, indicates that hyperspectral imaging is a simple exam that can easily be added to daily clinical practice and has the potential to provide useful information regarding the healing potential of DFU over a short period of time.     

Effect of honey dressing in the management of diabetic foot ulcers: A meta-analysis

A meta-analysis study to assess the effect of honey dressing (HD) in the management of diabetic foot ulcer (DFU). A comprehensive literature examination till January 2023 was implemented and 1794 linked studies were appraised. The picked studies contained 882 subjects with DFUs were in the picked studies' baseline, 424 of them were using HD, and 458 were using a control. Odds ratio (OR) in addition to 95% confidence intervals (CIs) were used to calculate the consequence of HD in the management of DFUs after DFU by the dichotomous and continuous styles and a fixed or random model. The HD applied to DFUs caused a significantly higher wound healing rate (OR, 2.06; 95% CI, 1.45-2.93, P < .001) and lower wound healing time (MD, −10.42; 95% CI, −16.27- −4.58, P < .001) compared with the control. The HD applied to DFUs caused a significantly higher wound healing rate and lower wound healing time compared with the control. Although precautions should be taken when commerce with the consequences since most of the picked studies for this meta-analysis was with low sample sizes.     

Microscopy visualisation confirms multi‐species biofilms are ubiquitous in diabetic foot ulcers

Increasing evidence within the literature has identified the presence of biofilms in chronic wounds and proposed that they contribute to delayed wound healing. This research aimed to investigate the presence of biofilm in diabetic foot ulcers (DFUs) using microscopy and molecular approaches and define if these are predominantly mono‐ or multi‐species. Secondary objectives were to correlate wound observations against microscopy results in ascertaining if clinical cues are useful in detecting wound biofilm. DFU tissue specimens were obtained from 65 subjects. Scanning electron microscopy (SEM) and peptide nucleic acid fluorescent in situ hybridisation (PNA‐FISH) techniques with confocal laser scanning microscopy (CLSM) were used to visualise biofilm structures. Next‐generation DNA sequencing was performed to explore the microbial diversity. Clinical cues that included the presence of slough, excessive exudate, a gel material on the wound bed that reforms quickly following debridement, poor granulation and pyocyanin were correlated to microscopy results. Of the 65 DFU specimens evaluated by microscopy, all were characterised as containing biofilm (100%, P < 0·001). The presence of both mono‐species and multi‐species biofilms within the same tissue sections were detected, even when DNA sequencing analysis of DFU specimens revealed diverse polymicrobial communities. No clinical correlations were identified to aid clinicians in identifying wound biofilm. Microscopy visualisation, when combined with molecular approaches, confirms biofilms are ubiquitous in DFUs and form either mono‐ or multi‐species biofilms. Clinical cues to aid clinicians in detecting wound biofilm are not accurate for use in DFUs. A paradigm shift of managing DFUs needs to consider anti‐biofilm strategies.     

Role of anaerobes in polymicrobial communities and biofilms complicating diabetic foot ulcers

Infected tissues in the feet of people with diabetes in the form of a diabetic foot ulcer (DFU) present a complex pathology for clinicians to manage. This is partly attributed to the multi‐factorial nature of the disease, which may include; altered foot architecture leading to excessive plantar pressures and frictional forces peripheral arterial disease and loss of protective sensation. In addition, to the above co‐morbid variables, it is understood that a delayed wound healing state may be perpetuated by the presence of microorganisms residing in the wound tissue. The microbiology of chronic DFUs has often been reported as being polymicrobial. Of growing interest is the presence and potential role of anaerobic microorganisms in the pathology of DFUs and how they may contribute to the infective process or delayed healing. The presence of anaerobes in DFUs has been greatly underestimated, largely due to the limitations of conventional culture methods in identifying them from samples. Advancements in molecular and microscopy techniques have extended our view of the wound microbiome in addition to observing the growth and behaviour (planktonic or biofilm) of microorganisms in situ. This review paper will reflect on the evidence for the role and significance of anaerobes in DFUs and infection. A focus of this review will be to explore recent advancements in molecular genomics and microscopy techniques in order to better assess the roles of anaerobic bacteria in chronic DFUs and in biofilm‐based wound care.     

A clinical trial of Integra Template for diabetic foot ulcer treatment

Individuals with diabetes mellitus are at an increased risk of developing a diabetic foot ulcer (DFU). This study evaluated the safety and efficacy of Integra Dermal Regeneration Template (IDRT) for the treatment of nonhealing DFUs. The Foot Ulcer New Dermal Replacement Study was a multicenter, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption. Thirty‐two sites enrolled and randomized 307 subjects with at least one DFU. Consented patients were entered into the 14‐day run‐in phase where they were treated with the standard of care (0.9% sodium chloride gel) plus a secondary dressing and an offloading/protective device. Patients with less than 30% reepithelialization of the study ulcer after the run‐in phase were randomized into the treatment phase. The subjects were randomized to the control treatment group (0.9% sodium chloride gel; n = 153) or the active treatment group (IDRT, n = 154). The treatment phase was 16 weeks or until confirmation of complete wound closure (100% reepithelialization of the wound surface), whichever occurred first. Following the treatment phase, all subjects were followed for 12 weeks. Complete DFU closure during the treatment phase was significantly greater with IDRT treatment (51%) than control treatment (32%; p = 0.001) at sixteen weeks. The median time to complete DFU closure was 43 days for IDRT subjects and 78 days for control subjects in wounds that healed. The rate of wound size reduction was 7.2% per week for IDRT subjects vs. 4.8% per week for control subjects (p = 0.012). For the treatment of chronic DFUs, IDRT treatment decreased the time to complete wound closure, increased the rate of wound closure, improved components of quality of life and had less adverse events compared with the standard of care treatment. IDRT could greatly enhance the treatment of nonhealing DFUs.     

The relationship between vitamin D deficiency and diabetic foot ulcer: A meta-analysis

A meta-analysis investigation to measure the relationship between vitamin D deficiency (VDD) and diabetic foot ulcer (DFU). A comprehensive literature inspection till February 2023 was applied and 1765 interrelated investigations were reviewed. The 15 chosen investigations enclosed 2648 individuals with diabetes mellitus in the chosen investigations' starting point, 1413 of them were with DFUs, and 1235 were without DFUs. Odds ratio (OR) in addition to 95% confidence intervals (CIs) were used to compute the value of the relationship between VDD and DFU by the dichotomous and continuous approaches and a fixed or random model. Individuals with DFUs had significantly lower vitamin D levels (VDL) (MD, −7.14; 95% CI, −8.83 to −5.44, P < 0.001) compared to those without DFU individuals. Individuals with DFUs had a significantly higher number of VDD individuals (OR, 2.27; 95% CI, 1.63-3.16, P < 0.001) compared to those without DFU individuals. Individuals with DFU had significantly lower VDL and a significantly higher number of VDD individuals compared to those without DFU individuals. However, caused of the small sample sizes of several chosen investigations for this meta-analysis, care must be exercised when dealing with its values.     

Management of diabetic foot ulcers and the challenging points: An endocrine view

Diabetic foot ulcers (DFU) are one of the most challenging complications of diabetes. Up to one-third of patients with diabetes mellitus (DM) may suffer from DFUs during their life. DFU is one of the leading causes of morbidity in patients with DM. The treatment period is challenging, and the recurrence rate of DFUs is high. Hence, establishing prevention strategies is the most important point to be emphasized. A multidisciplinary approach is necessary in the prevention and treatment of DFUs. Patients at risk should be identified, and prevention measures should be taken based on the risk category. Once a DFU is formed, the appropriate classification and evidence-based treatment interventions should be executed. Glycemic control, diagnosis and treatment of vascular disease, local wound care, diagnosis, and treatment of infection should be addressed along with the proper evaluation and management of general health status.     

Effect of ultrasound-supported wound debridement in subjects with diabetic foot ulcers: A meta-analysis

A meta-analysis study to assess the effect of ultrasound-supported wound debridement (USSD) in subjects with diabetic foot ulcer (DFU). A comprehensive literature examination till January 2023 was implemented and 1873 linked studies were appraised. The picked studies contained 577 subjects with DFUs in the studies' baseline, 282 of them were using USSD, 204 were using standard care, and 91 were using a placebo. Odds ratio (OR) in addition to 95% confidence intervals (CIs) were used to calculate the consequence of USSD in subjects with DFUs by the dichotomous styles and a fixed or random effect model. The USSD applied to DFU caused a significantly higher wound healing rate compared with the standard care (OR, 3.08; 95% CI, 1.94–4.88, P < .001) with no heterogeneity (I² = 0%) and the placebo (OR, 7.61; 95% CI, 3.11–18.63, P = .02) with no heterogeneity (I² = 0%). The USSD applied to DFUs caused a significantly higher wound healing rate compared with the standard care and the placebo. Though precautions should be taken when commerce with the consequences as all of the picked studies for this meta-analysis was with low sample sizes.     

A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers

The aim of this study was to determine the safety and effectiveness of dehydrated human umbilical cord allograft (EpiCord) compared with alginate wound dressings for the treatment of chronic, non‐healing diabetic foot ulcers (DFU). A multicentre, randomised, controlled, clinical trial was conducted at 11 centres in the United States. Individuals with a confirmed diagnosis of Type 1 or Type 2 diabetes presenting with a 1 to 15 cm² ulcer located below the ankle that had been persisting for at least 30 days were eligible for the 14‐day study run‐in phase. After 14 days of weekly debridement, moist wound therapy, and off‐loading, those with ≤30% wound area reduction post‐debridement (n = 155) were randomised in a 2:1 ratio to receive a weekly application of EpiCord (n = 101) or standardised therapy with alginate wound dressing, non‐adherent silicone dressing, absorbent non‐adhesive hydropolymer secondary dressing, and gauze bandage roll (n = 54). All wounds continued to have appropriate off‐loading during the treatment phase of the study. Study visits were conducted for 12 weeks. At each weekly visit, the DFU was cleaned and debrided as necessary, with the wound photographed pre‐ and post‐debridement and measured before the application of treatment group‐specific dressings. A follow‐up visit was performed at week 16. The primary study end point was the percentage of complete closure of the study ulcer within 12 weeks, as assessed by Silhouette camera. Data for randomised subjects meeting study inclusion criteria were included in an intent‐to‐treat (ITT) analysis. Additional analysis was conducted on a group of subjects (n = 134) who completed the study per protocol (PP) (EpiCord, n = 86, alginate, n = 48) and for those subjects receiving adequate debridement (EpiCord, n = 67, alginate, n = 40). ITT analysis showed that DFUs treated with EpiCord were more likely to heal within 12 weeks than those receiving alginate dressings, 71 of 101 (70%) vs 26 of 54 (48%) for EpiCord and alginate dressings, respectively, P = 0.0089. Healing rates at 12 weeks for subjects treated PP were 70 of 86 (81%) for EpiCord‐treated and 26 of 48 (54%) for alginate‐treated DFUs, P = 0.0013. For those DFUs that received adequate debridement (n = 107, ITT population), 64 of 67 (96%) of the EpiCord‐treated ulcers healed completely within 12 weeks, compared with 26 of 40 (65%) of adequately debrided alginate‐treated ulcers, P < 0.0001. Seventy‐five subjects experienced at least one adverse event, with a total of 160 adverse events recorded. There were no adverse events related to either EpiCord or alginate dressings. These results demonstrate the safety and efficacy of EpiCord as a treatment for non‐healing DFUs.     

Differentiating diabetic foot ulcers that are unlikely to heal by 12 weeks following achieving 50% percent area reduction at 4 weeks

This retrospective analysis included intent-to-treat control patient data from two published, randomised, diabetic foot ulcer (DFU) trials in an effort to differentiate ulcers that are unlikely to heal by 12 weeks despite early healing progress [≥50% percent area reduction (PAR) at 4 weeks]. Predicted and actual wound area trajectories in DFUs that achieved early healing progress were analysed from weeks 5 to 12 and compared for ulcers that did and did not heal at 12 weeks. In 120 patients who achieved ≥50% PAR by week 4, 62 (52%) failed to heal by 12 weeks. Deviations from the predicted healing course were evident by 6 weeks for non healing ulcers. A 2-week delay in healing significantly lowered healing rates (P = 0·001). For DFUs with ≥50% PAR at 4 weeks, those achieving ≥90% versus <90% PAR at 8 weeks had a 2·7-fold higher healing rate at 12 weeks (P = 0·001). A PAR of <90% at 8 weeks provided a negative predictive value for DFU healing at 12 weeks of 82%. For ulcers that fail to progress or worsen from weeks 4 to 6, and those that fail to achieve 90% PAR at 8 weeks, reevaluation of the wound and its treatment is recommended.     

Comparison of five systems of classification of diabetic foot ulcers and predictive factors for amputation

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.