Search

Objective : To evaluate the clinical efficacy of combining an offloading device with a contralateral shoe lift to compensate for induced limb-length discrepancies in participants with plantar diabetes-related foot ulcers. Approach : Between March 2021 and December 2023, 42 consecutive patients with active plantar diabetic foot ulcers (DFUs) were randomly assigned (1:1) to the treatment group (limb-length discrepancy compensation with a shoe lift in the therapeutic footwear of the contralateral limb) or a control group that did not receive limb-length discrepancy compensation. Primary outcomes included the 20-week wound-healing rate and wound area reduction. Secondary outcomes included minor amputation, new ulcers in the contralateral limb, perceived comfort, and hip pain. Results : On an intention-to-treat basis, 15 participants in the control and 19 in the treatment group showed ulcer healing ( p = 0.0023). In those with >80% adherence to the offloading device, multivariate analysis showed that the shoe lifts improved ulcer healing time. The use of a shoe lift reduced the number of minor amputations and the occurrence of new ulcers in the contralateral limb ( p = 0.035; p = 0.033 respectively). Hip pain and perceived comfort improved with the use of shoe lifts ( p < 0.001). Innovation : It validates the use of shoe lifts for patients with DFUs, as it is the first largest study of its kind to establish a clear reference standard to guide clinician decision-making. Conclusion : The use of shoe lifts reduced healing time in participants with diabetes and active plantar foot ulcers. Shoe lifts reduce late complications, including new ulcers in the contralateral limb and minor amputations.

Background: Charcot neuro-osteoarthropathy (CNO) is a rare but devastating complication of diabetes associated with high rates of morbidity; yet, many nonfoot specialists are unaware of it, resulting in missed and delayed diagnosis. Clinical practice guidelines (CPGs) have proven useful in improving quality of care and standardizing practice in diabetes and diabetic foot care. However, little is known about the consistency in recommendations for identification and management of active CNO. Aim: The aim of this study is to review European national diabetes CPGs for the diagnosis and management of active CNO and to assess their methodological rigor and transparency. Methods: A systematic search was performed to identify diabetes national CPGs across Europe. Guidelines in any language were reviewed to explore whether they provided a definition for active CNO and recommendations for diagnosis, monitoring, and management. Methodological rigor and transparency were assessed using the Appraisal of Guidelines for Research and Evaluation (AGREE-II) tool, which comprises 23 key items organized within six domains with an overall guideline assessment score of ≥ 60% considered to be of adequate quality to recommend use. Each guideline was assessed by two reviewers, and inter-rater agreement (Kendall's W ) was calculated for AGREE-II scores. Results: Seventeen CPGs met the inclusion criteria. Breadth of CNO content varied across guidelines (median (IQR) word count: 327; Q1 = 151; Q3 = 790), and 53% provided a definition for active CNO. Recommendations for diagnosis and monitoring were provided by 82% and 53%, respectively, with offloading being the most common management recommendation (88%). Four guidelines (24%) reached threshold for recommendation for use in clinical practice (≥ 60%) with the scope and purpose domain scoring highest (mean (SD): 67%, ± 23%). The remaining domains had average scores ranging between 19% and 53%. Inter-rater agreement was strong ( W = 0.882; p < 0.001). Conclusions: European national CPGs for diabetes provide limited recommendations on active CNO. All guidelines showcased deficits in their methodology, suggesting that more rigorous methods should be employed for diabetes CPG development across Europe., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2024 Nichola Renwick et al.)

Objective: To evaluate the cost-effectiveness of two 10% urea creams in patients with diabetic foot syndrome., Methods: This was a prospective, longitudinal, single-center, randomized, double-blind, prospective clinical trial that evaluated the skin quality of 20 feet belonging to 10 patients with diabetic foot syndrome after the application of two 10% urea creams purchased from pharmacies and supermarkets., Results: At follow-up, 19 (95%) of the participants' feet showed improved skin quality, irrespective of the cream applied. On visual inspection, participants had a decreased presence of xerosis, hyperkeratosis, and preulcerative signs such as subkeratotic bruising and areas of redness on the dorsum of the toes. At the 3-month follow-up, nine (90%) of the participants stated that they had continued to apply the cream as a method of self-management to prevent complications., Conclusions: Creams containing 10% urea purchased in supermarkets improve foot skin quality in patients with diabetic foot syndrome, regardless of their cost. Based on these findings, the authors recommend creams containing 10% urea as a self-management tool for patients with diabetic foot syndrome., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Punch grafting is an alternative treatment to enhance wound healing which has been associated with promising clinical outcomes in various leg and foot wound types. We aimed to evaluate the clinical outcomes of punch grafting as a treatment for hard-to-heal diabetic foot ulcers (DFUs). Six patients with chronic neuropathic or neuroischemic DFUs with more than 6 months of evolution not responding to conventional treatment were included in a prospective case series between May 2017 and December 2020. All patients were previously debrided using an ultrasound-assisted wound debridement and then, grafted with 4 to 6 mm punch from the donor site that was in all cases the anterolateral aspect of the thigh. All patients were followed up weekly until wound healing. Four (66.7%) DFUs were located in the heel, 1 (16.7%) in the dorsal aspect of the foot and 1 (16.7%) in the Achilles tendon. The median evolution time was 172 (interquartile range [IQR], 25th-75th; 44-276) weeks with a median area of 5.9 (IQR; 1.87-37.12) cm 2 before grafting. Complete epithelization was achieved in 3 (50%) patients at 12 weeks follow-up period with a mean time of 5.67 ± 2.88 weeks. Two of the remaining patients achieved wound healing at 32 and 24 weeks, respectively, and 1 patient showed punch graft unsuccessful in adhering. The median time of wound healing of all patients included in the study was 9.00 (IQR; 4.00-28.00) weeks. The wound area reduction (WAR) at 4 weeks was 38.66% and WAR at 12 weeks was 88.56%. No adverse effects related to the ulcer were registered through the follow-up period. Autologous punch graft is an easy procedure that promotes healing, achieving wound closure in chronic DFUs representing an alternative of treatment for hard-to-heal DFUs in which conservative treatment has been unsuccessful.

A systematic review of the effectiveness of off-loading in the diabetic foot was done. Searches were conducted in October 2022 using the PubMed and Scielo databases. Randomized clinical trials or controlled clinical trials were included. Two authors performed the study selection and data extraction, and any discrepancies between the 2 reviewers were resolved through discussion with a third reviewer. Fourteen papers met the selection criteria with 822 patients included, but the sample sizes in all studies were small. Most of the published studies were done in European countries. Total contact cast was the most effective off-loading. The present review studies the effectiveness of off-loading systems in patients with diabetic foot ulcer, as well as different off-loading methods, with total contact cast proving to be the gold standard, despite its adverse effects.

Aim: To compare the healing time in patients with diabetic foot osteomyelitis according to the presence or absence of clinical signs of infection, variation of blood parameters, the presence of different radiological signs, and the treatment received for the management of osteomyelitis., Methods: A prospective observational study was carried out in a specialised Diabetic Foot Unit between November 2014 and November 2018. A total of 116 patients with osteomyelitis were included in the study (treated by either a surgical or medical approach). During the baseline visit, we assessed the diagnosis of osteomyelitis, demographic characteristics and medical history, vascular and neurological examination, clinical signs of infection, increased blood parameters, radiological signs of osteomyelitis, and the treatment to manage osteomyelitis. We analysed the association between the presence of clinical signs of infection, variation of blood parameters, presence of radiological signs, and treatment received for management of osteomyelitis with the healing time., Results: The mean time to ulcer healing was 15.8 ± 9.7 weeks. Concerning healing times, we did not find an association with the presence of clinical signs of infection or with the increase in blood parameters, except in the case of eosinophils, which with higher values appear to increase the healing time (U = 66, z = -2.880, p = 0.004). Likewise, no relationship has been found between healing time and the appearance of the different radiological signs of osteomyelitis, nor depending on the treatment administered for the management of osteomyelitis., Conclusion: High levels of eosinophils are associated with a longer healing time of diabetic foot ulcers complicated with osteomyelitis, finding no other factors related to increased healing time.

Objective: To analyze the association between radiologic changes on plain X-rays in patients with diabetic foot osteomyelitis and the development of complications at the 1-year follow-up., Methods: A prospective, observational study was conducted involving 115 patients with diabetic foot osteomyelitis. X-ray features that were evaluated during 1-year follow-up visits included affected bone marrow, active periosteal reaction, sequestrum, cortical disruption, and other types of signs. Researchers analyzed the association between the presence of X-ray changes and complication development, such as bone or soft tissue infections, ulcer recurrence, reulceration, amputation, death, and other diabetic foot disease-related events., Results: During follow-up, of 115 patients included in the study, 33 patients (28.7%) showed radiologic changes, and 85 (73.9%) developed complications. The presence of radiologic changes after ulcer healing had a significant association with complication development during the 1-year follow-up in addition to those found at different follow-up visits. Patients who showed radiologic changes had higher percentages of complications during the 1-year follow-up, and patients without radiologic changes had lower percentages of complications., Conclusions: The presence of radiologic changes is related to the development of complications in patients who suffer from diabetic foot osteomyelitis., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: To assess long-term clinical outcomes of patients who underwent isolated versus several percutaneous flexor tenotomies for the treatment of toe deformities and previous diabetic foot ulcers; Methods: Twenty-three patients (mean age 66.26 ± 11.20, years) who underwent prophylactic percutaneous flexor tenotomies secondary to tip-toe ulcers participated in this 1-year prospective study. The study was stratified into two groups for analyses: (1) isolated tenotomies patients, and (2) several tenotomies patients (two or more tenotomies). Outcome measures were toe reulceration and recurrence, minor lesions, digital deformities, and peak plantar pressure (PPP—N/cm2) and pressure/time Integral (PTI—N/cm2/s) in the hallux and minor toes after a 1-year follow-up period; Results: Patients with isolated tenotomies (n = 11, 35.48%) showed a higher rate of reulceration (n = 8, 72.7%, p < 0.001) in the adjacent toes, additionally, we found more prevalence of hyperkeratosis (n = 11, 100%), minor lesions (n = 9, 81%), and claw toes (n = 11, 100%) (p < 0.001). In several tenotomies patients (n = 20, 64.52%), we found a higher rate of floating toes (n = 16, 80%) in comparison with isolated tenotomies patients (p < 0.001). PPP and PTI in the non-tenotomy toes were higher in the group of patients who underwent isolated tenotomies (p < 0.001); Conclusions: Patients who underwent several tenotomies had better clinical outcomes after a 1-year follow-up period compared to isolated tenotomies.

Objective: To analyze and compare the development of short- and long-term complications in patients with diabetic foot after digital arthroplasty or arthrodesis., Methods: The authors reviewed patient records from January 2017 to March 2020. Patients were treated by digital arthroplasty or arthrodesis to correct toe deformity (elective or prophylactic surgery), achieve ulcer healing in toes (curative surgery), or manage toe infection (emergent surgery). During 1-year follow-up, researchers registered short- and long-term complications. Researchers analyzed the association between the type of surgery and the development of short- and long-term complications., Results: Forty-four patients (83.0%) received arthroplasty, and nine (17.0%) received arthrodesis. The mean time to heal from ulcers was 5.2 ± 5.2 weeks. A significant association was observed between arthrodesis and the development of long-term complications (P = .044; odds ratio, 5.1; 95% confidence interval, 0.9-27.2). No differences were observed between type of surgery and short- or long-term complications. Moreover, both short- and long-term complications were related to longer time to heal (respectively, 7.6 ± 6.0 vs 2.1 ± 0.5 weeks, P < .001; and 6.3 ± 6.2 vs 4.2 ± 4.0 weeks, P = .039)., Conclusions: Digital arthroplasty or arthrodesis are good options for managing patients with diabetic foot who require digital deformity correction to achieve digital ulcer healing or management of diabetic foot infection in phalanges., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Aims: To analyze a plantar pressure cut-off point for diabetic foot reulceration beneath the metatarsal heads in patients with previous forefoot amputation., Methods: A one-year prospective study was conducted in a total of 105 patients at high risk for foot ulceration. Peak plantar pressure (PPP) and pressure-time integral (PTI) in the entire foot, the forefoot region, and each metatarsal head separately were registered. ROC curves were used to select the optimal diagnostic pressure cut-off points. Patients were follow-up monthly or until the development of an ulcer event., Results: A total of 52 (49.5%) patients developed a reulceration. Using ROC analyses for PPP in the full-foot and in the forefoot, did not predict reulceration beneath the metatarsal heads. Analyzing separately each metatarsal head all patients with values greater than or equal to 20.8 N/cm 2 at the 1st, 18.62 N/cm 2 for the 2nd, 18.85 at the 3rd, 17.88 at the 4th, and 12.2 at the 5th metatarsal heads will suffer a reulceration despite the use of orthopedic treatment with optimum values of sensitivity (from 100 to 87.5) and specificity (from 83.2 to 62.8)., Conclusion: Barefoot pressures beneath the metatarsal heads should be analyzed separately to predict the region at risk of reulceration., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: To identify differences in radiographic outcomes in weight-bearing lateral X-ray to predict the probability of ulceration in patients with midfoot Charcot neuroarthropathy (CN) differentiated by lateral and medial column deformities., Methods: Thirty-five patients who suffered from CN midfoot deformity participated in this 1 year prospective study in a specialized diabetic foot unit. Lateral talar-first metatarsal angle, calcaneal pitch, and cuboid height were performed by digital radiographs in the weight-bearing lateral view. Patients were followed up for 1 year or until an ulcer ulceration event occurred in the midfoot region., Results: ROC analyses showed that all patients with medial pattern deformity that developed a midfoot ulcer had a lateral talar-first metatarsal angle greater (negative) than -27.5 degrees (°). All patients with lateral pattern deformity that developed a midfoot ulcer had a calcaneal pitch greater (more negative) than -5° and a cuboid height greater (more negative) than -1.5°., Conclusions: Lateral talar-first metatarsal angle was the greatest predictor of midfoot ulceration, with greater than -27.5° measurement correlating with ulceration occurrence in patients with medial deformity. Calcaneal pitch and cuboid height were the greatest predictors of midfoot ulceration with greater than -5 and -1.5°, respectively in patients with CN lateral deformity.

Introduction: The knowledge about level of adherence to oral antibiotic treatment in diabetic patients with ulcer infection could be essential as a method of evaluation/monitoring of conservative treatment. Aim: To assess the adherence to oral antibiotic treatment in outpatients with diabetic foot infection (soft tissue vs. osteomyelitis) by 8-item structured, self-reported medication adherence scale. Methods: cross-sectional study was carried out with 46 consecutive patients who had diabetic foot infection (soft tissue or bone infection) and required antibiotic oral treatment at outpatient clinical setting. Medication adherence was tested using the Spanish version of the validated eight-item self-report MMAS-8. Results: patients with diabetic ulcer infection, had well level of adherence to antibiotic medication (7   ±   1.2 vs. 7.4   ±   1.5). Patients with lower level of adherence had lower level of satisfaction with the antibiotic medication. The profile of the patients with lower level of adherence were patients with primary level of education and patient who required more help to take the medication. Conclusion: Patients with diabetic foot infection demonstrated well level of adherence to antibiotic medication, independently of type of infection (soft tissue vs. osteomyelitis) by 8-item structured, self-reported medication adherence scale.

Aim: To compare long-term complications according to the treatment received for management of diabetic foot osteomyelitis (surgical or medical) at 1 year follow up., Design and Participants: A prospective observational study was conducted involving 116 patients with diabetic foot osteomyelitis. The patients received surgical or medical treatment based on the principles described in the literature. To register the development of a complication, both groups of treatments were followed-up 1 year after the ulcer had healed., Results: Ninety-six (82.8%) patients received surgical treatment and 20 (17.2%) medical treatment. No differences were found in the time to healing between both groups of treatment, 15.7 ± 9.2 weeks in the surgical group versus 16.4 ± 12.1 weeks in the medical group; p = 0.103. During follow up, 85 (73.3%) patients developed complications without differences between both groups, 68 (70.8%) in the surgical group versus 17 (85%) in the medical group ( p = 0.193). The most common complication in both groups was re-ulceration. We did not observe significant differences comparing complication-free time survival between both treatments ( p = 0.665)., Conclusion: The onset of complications after healing in patients who suffered from diabetic foot osteomyelitis was not associated with the treatment received. Surgical and medical approaches to the management of diabetic foot osteomyelitis produced similar results in long-term follow up.

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.)

A systematic review and quality assessment was performed to assess the management of diabetic foot osteomyelitis by medical or surgical treatment. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist was used. All selected studies were evaluated using the Cochrane Risk of Bias Tool to assess the risk of bias for randomized controlled trials. The literature was revised using PubMed (Medline) and Embase (Elsevier) up to September 2020 to identify clinical trials assessing medical or surgical treatment to manage diabetic foot osteomyelitis. A total of six clinical trials that met our inclusion criteria, with a total of 308 participants. Healing rate, complete closure of the wound, and type of complications were the outcomes evaluated. Risk of bias assessment showed that only two of the six clinical trials included in the systematic review had a low risk of bias. Based on our findings, we believe that the management of diabetic foot osteomyelitis remains challenging. There are few high-quality clinical trials that both stratify clinical presentations and compare these treatments. We conclude that the available evidence is insufficient to identify the best option to cure diabetic foot osteomyelitis.

Objective: The use of emollients to lubricate dry skin to prevent diabetic foot ulcers (DFUs), especially in neuroischaemic feet, has been recommended. This study analyses the effect of daily topical application of hyperoxygenated fatty acids emulsion on transcutaneous oxygen pressure (TcPO 2 ) in the feet of neuropathic and neuroischaemic patients with diabetes., Method: Patients with diabetes and no active foot ulcer were included in this longitudinal, prospective, non-comparative clinical trial. The evolution of TcPO 2 (mmHg) values after the application of the tested emulsion (Corpitol Emulsion, Laboratoires Urgo Medical, France) was evaluated for a three-month period. Modifications of skin features (skin dryness, skin shedding and skin colour) were also analysed. TcPO 2 was performed using a TCM400 device (Radiometer, Denmark)., Results: A total of 50 patients were included in the study. Patients with neuroischaemia showed a significant increase in TcPO 2 values (35.69±13.88mmHg) after two months' application of the tested emulsion that remained at month three (day 60: 42.34±10.98mmHg; p=0.006; day 90: 41.62±10.88mmHg; p=0.011). Skin dryness and shedding showed an improvement from baseline to the end of the study in both groups, secondary to the use of the tested emulsion (p<0.001 and p<0.001, respectively). Skin colour also showed differences from baseline to the final visit in the neuroischaemic patients (p=0.029). Patients with neuropathy did not show any change in skin colour from baseline to the final visit., Conclusions: Analysis of the use of the tested emulsion showed an increase in TcPO 2 and an improvement in skin trophism in patients with neuroischaemic foot.

There are a wide variety of treatments for plantar warts, but none has been shown to be effective in all patients. We aimed to perform a systematic review of the efficacy of different topical treatments on plantar warts. Systematic electronic searches (Pubmed, Cochrane Library, Embase, and Web of Science) were conducted in April 2020. Meta-analyses, systematic reviews, and retrospective or prospective clinical trials of the effects of topical and nonsurgical treatments of plantar warts were included. Two authors performed the study selection and data extraction. Any discrepancies between the two reviewers were discussed with a third reviewer. Forty-four studies were included. The average cure rates of the most frequent treatments were variable across the studies: cryotherapy (45.61%), salicylic acid (13.6%), cantharidin-podophyllin-salicylic acid formulation (97.82%), laser (79.36%), topical antivirals (72.45%), intralesional bleomycin (83.37%), and intralesional immunotherapy (68.14%). Twenty-two studies (50%) had a level of evidence 1b and grade of recommendation A, five studies (11.4%) had a level of evidence 2b and grade of recommendation B, two studies (4.5%) had a level of evidence 3b and grade of recommendation B, and 15 studies (34,1%) with a level of evidence 4 and grade of recommendation C. First-choice treatments for common warts, such as cryotherapy and salicylic acid, have low-cure rates for plantar warts. Other treatments, such as CPA formulation, immunotherapy, and intralesional bleomycin, which have compassionate use, have higher cure rates. This review should stimulate future high-quality research to evaluate these specialized treatments., (© 2020 Wiley Periodicals LLC.)

Osteomyelitis (OM) is the most frequent infection associated with diabetic foot ulcers (DFU) that typically involve the forefoot, the most common location of DFU. Conservative surgical procedures could be attractive alternative that reduces minor and major amputations and avoid future recurrence thus preserving the functionally of the foot. This review aimed to analyze and describe the current evidence on conservative diabetic foot osteomyelitis (DFO) surgical procedures depending on DFU location and indications. A narrative revision of the evidence was carried out by searching Medline through PubMed databases from inception to late July 2020 to identify retrospective, prospective, and randomized controlled trials pertaining to conservative DFO procedures on the forefoot. Seven types of conservative surgical procedures for DFO treatment in the forefoot are described in this review: (1) partial or total distal phalangectomy, (2) arthroplasty of the proximal or distal interphalangeal joint, (3) distal Syme amputation, (4) percutaneous flexor tenotomy, (5) sesamoidectomy, (6) arthroplasty of the metatarsophalangeal joint, and (7) metatarsal head resection. When indicated, conservative surgery for DFUs in patients with chronic forefoot OM is a safe and effective option that increases the chances of healing and reduces the possibility of limb loss and death compared with radical amputation procedures. Since a lack of sufficient evidence supporting this procedure exists, future investigations should be focused on the random clinical trial (RCT) design. The results of prospective trials could help surgeons select the appropriate procedure in each case in order to minimize complications., Competing Interests: No conflict of interest has been declared by the author(s)., (© 2020 Delhi Orthopedic Association. All rights reserved.)

The evidence is still unclear regarding the role of blood parameters in detecting complications in patients who suffer from diabetic foot osteomyelitis (DFO). In this study, the aim was to identify the capacity of different blood parameters in the diagnosis and prediction of the onset of complications. A cross-sectional prospective study was carried out with 116 DFO patients. The following blood parameters were evaluated during 1 year of follow-up: leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, erythrocyte sedimentation rate (ESR), glycemia, glycosylated hemoglobin, C-reactive protein (CRP), alkaline phosphatase, albumin, and creatinine. Complication events were assessed for each participant during the study period. We investigated the association between blood parameter values and the onset of complication events by conducting a receiver operating characteristic curve analysis. Eighty-five (73.3%) patients developed complications. Regarding blood parameters, higher values of lymphocytes and albumin were predictive factors at the 12-month follow-up once the ulcer had healed. Higher values of ESR had predictive and diagnostic value for the onset of complication events, and higher values of CRP and hyperglycemia were diagnostic factors since they were elevated during the occurrence of an event. In conclusion, after suffering from DFO, the elevation of lymphocytes, ESR, CRP, albumin, and glycemia could be useful in detecting and diagnosing patients who are likely to develop a complication. Serial blood tests are a useful tool for early detection by healthcare professionals to prevent complications.

This review provides an outline of the use of adipose-derived mesenchymal stem cells (AMSCs) in the treatment of diabetic foot ulcers (DFUs). A systematic search of PubMed and the Cochrane database was performed on October 2, 2019. Eighteen studies were identified (14 preclinical and 4 clinical). Studies in animal models have demonstrated that AMSCs enhance diabetic wound healing, accelerate granulation tissue formation, and increase reepithelialization and neovascularization. Only 1 randomized control trial has been published so far. Patients (n = 25) with DFUs were treated using an allogeneic AMSC directly on the wound bed as a primary dressing, and improvements were found in complete wound closure in the treatment group (n = 16). Three clinical studies showed that autologous AMSC might be a safe alternative to achieve therapeutic angiogenesis in patients with diabetes and peripheral arterial disease. Based on the available evidence, AMSCs hold promise in the treatment of DFUs. However, this evidence requires confirmation by well-designed trials. Additional studies are also required to understand some issues regarding this treatment for DFUs. For example, the potential application of autologous or allogeneic AMSCs in different types of DFUs, optimal dose/infusion schedules, safety evaluations, and cost-effectiveness.

A systematic review and proportional meta-analysis were carried out to investigate the complications that occur after surgical metatarsal head resection in diabetic foot patients. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist recommendations were applied, and the selected studies were evaluated using a Strengthening the Reporting of Observational studies in Epidemiology (STROBE) checklist. PubMed (Medline) and Embase (Elsevier) were searched in December 2019 to find clinical trials, cohort studies, or case series assessing the efficacy of the metatarsal head resection technique in diabetic foot patients. The systematic review covered 21 studies that satisfied the inclusion criteria and included 483 subjects. The outcomes evaluated were the time to heal, recurrence, reulceration, amputation, and other complications. The proportion of recurrence was 7.2% [confidence interval (CI) 4.0-10.4, p < 0.001], that of reulceration was 20.7% (CI 11.6-29.8, p < 0.001), and that of amputation was 7.6% (CI 3.4-11.8, p < 0.001). A heterogeneity test indicated I 2 = 72.6% ( p < 0.001) for recurrences, I 2 = 94% ( p < 0.001) for reulcerations, and I 2 = 79% ( p < 0.001) for amputations. We conclude that metatarsal head resections in diabetic foot patients are correlated with significant complications, especially reulceration.

Objective: To analyse the predictive role of inflammatory markers in the healing time of diabetic foot osteomyelitis treated by surgery or antibiotics., Methods: An observational study of patients with diabetic foot ulcers (DFU) and clinically suspected osteomyelitis. The patients underwent surgical or antibiotic treatment for bone infection in a specialised diabetic foot unit. Blood samples were taken from each patient to analyse biomarkers. The main outcome was the number of weeks until healing occurred., Results: A total of 116 patients took part in the study. The number of weeks until healing was similar for both groups (surgical n=96 and antiobiotic n=20, treatments). No association was observed among biomarkers as predictors of time-to-healing., Conclusion: There is not enough evidence to define the prognostic role of inflammatory markers in the healing time of DFUs complicated with diabetic foot osteomyelitis, regardless of the treatment administered.

The aim of this study is to evaluate the prevalence of digital deformities in patients with diabetes mellitus according to the McGlamry classification and relate the types of digital deformities with the history of digital ulcer. A cross-sectional study was performed in the diabetic foot unit between September 2016 and September 2017. All consecutive patients were classified by digital deformities according to the McGlamry classification (flexor stabilization, flexor substitution, and extensor substitution) using slow-motion videos. In all patients, the Foot Posture Index 6 was performed and previous toe ulceration, toe calluses, and nail dystrophy were evaluated. A total of 142 feet were evaluated, in which 29 (20.27%) feet did not show dynamic deformities, 65 (57.5%) were classified as flexor stabilization, 9 (8%) as flexor substitution, and 39 (34.5%) as extensor substitution. In total, 23% the feet with previous ulcer were classified as extensor substitution. A previous toe ulcer on the tip (p = .033; confidence interval [CI] 1.06 to 4.99; odds ratio [OR] 2.3), pronated foot according to the Foot Posture Index 6 (p = .048; 95% CI 0.9 to 8.9; OR 2.9), and callus on the tip (p = .002; 95% CI 1.47 to 6.41; OR 3.07) were associated with flexor stabilization deformities. Flexor stabilization, associated with the pronated foot, was the most prevalent dynamic deformity. Extensor substitution was present in approximately 40% of the patients and in 20% of the patients with previous ulcer, in whom flexor tenotomy could aggravate the digital deformity. An evaluation of dynamic deformities during gait should be included as a presurgical assessment to achieve successful surgical results., (Copyright © 2018 the American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.)

The aim of this study was to evaluate the recovery time and the development of complications in the dorsal and plantar approach to metatarsal head resections (MHR) in patients with diabetic foot ulcers complicated by osteomyelitis. A retrospective study was carried out involving 108 patients who underwent MHRs for the treatment of diabetic foot osteomyelitis. Two cohorts were defined: dorsal approach with incision closed with sutures and plantar approach with ulcer healed using conservative treatment. The main outcomes were the weeks until healing and complications related to the approaches. Fifty-three patients (49.1%) underwent a plantar approach and 55 (50.9%) a dorsal approach. Both approaches rendered similar healing times. However, the patients undergoing a dorsal approach developed more post-surgical complications than patients treated through a plantar approach. The dorsal approach intervention was performed on smaller and shallower ulcers; however, more complications developed at follow up using this approach than through a plantar approach for MHR complicated with osteomyelitis., (© 2018 Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Objective: To analyze the correlation between empirical antibiotic therapies prescribed in primary care centers by general practitioners and the microbiology results of bone culture in patients with diabetic foot-related osteomyelitis., Methods: This observational study involved 80 patients with diabetic foot ulcers and clinically suspected osteomyelitis. The patients were taking antibiotics prescribed by general practitioners to treat diabetic foot infections. Bone samples were taken from every patient for microbiology analysis in a specialized diabetic foot unit., Main Outcome Measure: The sensitivity of the bone cultures to antibiotics was compared with the patient's previous antibiotic therapy, and antibiotic and bacterial resistance were analyzed., Main Results: The bone cultures from only 16 patients (22.3%) showed sensitivity to the antibiotics that the patient had been prescribed. Fifty-six patients (77.8%) displayed bacterial resistance to the antibiotic that they were taking., Conclusions: Awareness and implementation of international antibiotic stewardship guidelines are poor in primary care centers. It is important to establish strategies that foster a better understanding of treatment management standards and ensure the proper implementation of guidelines.

Aims: To evaluate the utility of the sudomotor function test (SFT) as a clinical tool in the Risk Stratification System of diabetic patients and to demonstrate the earlier detection of the risk of developing diabetic foot ulcers (DFU) compared to the standard clinical tests., Methods: Prospective follow-up study on 263 patients enrolled consecutively over 3.5 years. Diabetic patients without active DFU were classified according to the International Working Group Risk Stratification System (RSS) and categorized according to the results of the Semmes-Wenstein Monofilament (SWM) and biothesiometer measurements or the SFT. The main outcome evaluated was the development of DFU., Results: Median follow-up was 42 [38-44] months. Sixty patients (22.8%) developed DFU after a median of 6.2 [3-17] months. Ten patients that were included in the no-risk group (group 0) based on the SWM and biothesiometer results developed DFU. Thus the sensitivity of this approach was 83.33% and the specificity was 50.47%. Based on the SFT results, all patients that developed DFU were included in the correct risk group. This approach had 100% sensitivity and 31.53% specificity. Regarding the diagnostic accuracy of the two Methods, the respective AUC values were 0.776 (95% CI 0.702-0.849) and 0.816 (95% CI 0.757-0.874)., Conclusions: SFT improved RSS in diabetic patients in a specialized diabetic foot unit. SFT categorized patients correctly according to the risk of developing DFU., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Quantitative ultrasound imaging of the muscle tissue may be applied in the neurology field, due to B-mode grayscale pixels values could be used as potential biomarkers for disease progression and intervention effects in poststroke patients. Thus, the study aim was to compare and analyze the ultrasound imaging B-mode pixels differences between the intrinsic plantar muscles cross-sectional area (CSA) in hemiparetic and contralateral feet from poststroke patients by means of the Image J software. A case-control design and a convenience sampling method were used in order to recruit 22 feet from 11 poststroke patients. This total sample was divided into 11 hemiparetic feet and 11 contralateral feet. The Image J software was used in order to evaluate the interface distance, CSA as well as measure the pixels mean, standard deviation (SD) and count from all offline images in the flexor digitorum brevis, abductor hallucis (AbH), and flexor hallucis brevis muscles. Statistically significant differences ( p = 0.003) were only shown for the pixels count in the AbH muscle. The rest of outcome measurements did not show any statistically significant difference ( p > 0.05). Therefore, B-mode ultrasound imaging Image J software differences for the pixels count reduction were shown in the AbH muscle between hemiparetic and contralateral feet from poststroke patients. Further studies are necessary in order to apply our findings as potential biomarkers during the stroke disease course.

Objective: We conducted a prospective pilot study in patients with diabetes to analyse the interobserver reliability of the ankle-brachial index, toe-brachial index and distal pulse palpation depending on the training of the professional involved., Materials and Methods: The ankle-brachial index, toe-brachial index and distal pulses were assessed by three clinicians with different levels of experience on the same day. Measurements were supervised and recorded by a fourth clinician., Results: Twenty-one patients (42 ft) were included in this study. We observed moderate agreement between clinicians in the palpation of posterior tibial arteries (K = 0.45, p < 0.001) and low agreement in dorsalis pedis arteries (K = 0.33, p < 0.001). The measurement of ankle-brachial index had moderate agreement between clinicians in patients with medial arterial calcification (K = 0.43, p < 0.001) and low agreement in patients with normal ankle-brachial index (K = 0.4, p < 0.001). The measurement of toe-brachial index had moderate agreement between clinicians in patients with a normal toe-brachial index (K = 0.4, p < 0.001) and in patients with medial arterial calcification (K = 0.60, p < 0.001)., Conclusion: Palpation of distal pulses, ankle-brachial index and toe-brachial index determination in patients with diabetes are not highly reproducible and reliable between clinicians with different levels of experience under routine conditions.

Background: There is a current lack of sufficiently high-quality randomized controlled clinical trials that measure the effectiveness of neural tissue mobilization techniques such as median nerve neural mobilization (MNNM) and their specific effects on cervicobrachial pain (CP). The aim of this study was to compare the effectiveness of MNNM in subjects with CP vs. a waiting list control group (WLCG)., Methods: A single-blinded, parallel, randomized controlled clinical trial was performed (NCT02596815). Subjects were recruited with a medical diagnosis of CP corroborated by magnetic resonance imaging. In total, 156 individuals were screened, 60 subjects were recruited, and 51 completed the trial. Pain intensity reported using the Numeric Rating Scale for Pain (NRSP; primary outcome), cervical range of motion (CROM), and functionality using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scale were the outcome measurements. Assessments were conducted at baseline and 1 hour after treatment (intervention days 1, 15, and 30). Therefore, MNNM was implemented with 30 days of follow-up., Results: The NRSP values of the MNNM group were significantly (P < 0.0001; 95% confidence interval [CI]) superior to those obtained in the WLCG. Subjects treated with MNNM reported an NRSP decrease of 3.08 points at discharge. CROM and QuickDASH outcome values were significantly (P ˂ 0.0001; 95% CI) improved only in the MNNM group. Hedges' g showed a very large effect of the MNNM intervention., Conclusion: MNNM may be superior to no treatment in reducing pain and increasing function in the affected upper limbs of subjects with CP., (© 2017 World Institute of Pain.)

Purpose: This study aim was to compare the effectiveness of the median nerve neural mobilization (MNNM) and cervical lateral glide (CLG) intervention versus oral ibuprofen (OI) in subjects who suffer cervicobrachial pain (CP). Methods: This investigation was a, multicenter, blinded, randomized controlled clinical trial (NCT02595294; NCT02593721). A number of 105 individuals diagnosed with CP were enrolled in the study and treated in 2 different medical facilities from July to November 2015. Participants were recruited and randomly assigned into 3 groups of 35 subjects. Intervention groups received MNNM or CLG neurodynamic treatments, and the (active treatment) control group received an OI treatment for 6 weeks. Primary outcome was pain intensity reported through the Numeric Rating Scale for Pain (NRSP). Secondary outcomes were physical function involving the affected upper limb using the Quick DASH scale, and ipsilateral cervical rotation (ICR) using a cervical range of motion (CROM) device. Assessments were performed before and 1 hour after treatment for NRSP (baseline, 3 and 6 weeks) and CROM (baseline and 6 weeks), as well as only 1 assessment for Quick DASH (baseline and 6 weeks). Results: Repeated-measures ANOVA intergroup statistically significant differences were shown for CP intensity (F (2,72) = 22.343; P < .001; Eta 2 = 0.383) and Quick DASH (F (2,72) = 15.338; P < .001; Eta 2 = 0.299), although not for CROM (F (2,72) = 1.434; P = .245; Eta 2 = 0.038). Indeed, Bonferroni´s correction showed statistically significant differences for CP intensity ( P < .01; 95% CI = 0.22 - 3.26) and Quick DASH reduction ( P < .01; 95% CI = 8.48 - 24.67) in favor of the OI treatment at all measurement moments after baseline. Conclusions: OI pharmacologic treatment may reduce pain intensity and disability with respect to neural mobilization (MNNM and CLG) in patients with CP during six weeks. Nevertheless, the non-existence of between-groups ROM differences and possible OI adverse effects should be considered., Competing Interests: Competing Interests: The authors have declared that no competing interest exists.

Background: Cervicobrachial pain (CP) is a high-incidence and prevalent condition. Cervical lateral glide (CLG) is a firstline treatment of CP. There is a current lack of enough high-quality randomized controlled double-blind clinical trials that measure the effectiveness of neural tissue mobilization techniques such as the CLG and its specific effect over CP., Objectives: The aim of the present study was to assess the effect of CLG neural mobilization in treating subjects who suffer from CP, compared with the complete absence of treatment., Study Design: This investigation was a single-center, blinded, parallel randomized controlled clinical trial (RCT)., Setting: One hundred forty-seven individuals were screened in a medical center from July to November 2015. Fifty-eight participants were diagnosed with CP., Methods: Participants were recruited and randomly assigned into two groups of 29 subjects. The intervention group received CLG treatment, and the control group (CG) was assigned to a six-week waiting list to receive treatment. Randomization was carried out by concealed computer software randomized printed cards. The primary outcome was pain intensity, reported through the Numeric Rating Scale for Pain (NRSP). Secondary outcomes were physical function involving the affected upper limb using the Quick DASH scale and ipsilateral cervical rotation (ICR) using a CROM device. Assessments were made at baseline and one hour after treatment., Results: The CLG group NRSP mean value was significantly (P < 0.0001) superior to those obtained by the CG. Subjects treated with CLG reported an average NRSP decrease of 2.16 points (35%). CROM device and Quick DASH outcome values also reported significant (P < 0.0001) improvements only in the CLG group. Cohen's d showed a very large effect of the CLG intervention at subject discharge., Limitations: Due to the lack of dipper subgroup analysis and additional reproductions of the applied protocol, the authors considered the generalization of the study results to be impossible., Conclusions: CLG is superior to the absence of treatment in reducing pain and increasing the affected upper limb function of subjects who suffer from CP. CLG may be considered an effective treatment in specific cases of CP., (© 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com)

Objective: To date, the minimum clinical differences (MCDs) in the pressure pain thresholds (PPTs) of the upper trapezius and temporalis muscles have not yet been established in participants with tension-type headache (TTH). The purpose of the study was to evaluate the MCDs of the PPTs of the upper trapezius and temporalis in participants with TTH and those without TTH., Methods: The sample comprised 120 participants with TTH (n = 60; mean [standard deviation] years = 38.30 [10.05]) and without TTH (n = 60; 34 [8.20]). The participants were recruited from an outpatient clinic in Spain from 2014 to 2016. The PPTs of the most hyperalgesic trigger points of the upper trapezius and temporalis were assessed., Results: There were statistically significant differences, mean (standard deviation) kg/cm 2 , for the right upper trapezius PPT (P < .001; 1.52 [0.35] vs 2.37 [0.49]), the left upper trapezius PPT (P < .001; 1.53 [0.36] vs 2.29 [0.49]), the right temporalis PPT (P = .008; 1.56 [0.31] vs 1.72 [0.33]), and the left temporalis PPT (P = .001; 1.57 [0.27] vs 1.74 [0.30]) between participants with and without TTH, respectively., Conclusions: The PPT MCDs for the right and left upper trapezius and the right and left temporalis were 0.85, 0.76, 0.16, and 0.17 kg/cm 2 , respectively, for the clinical management of trigger points in participants with TTH., (Copyright © 2017. Published by Elsevier Inc.)

The aim of this article was to assess the ability to predict reulceration in people with diabetes and a history of minor amputation according to the formula proposed by Miller et al. A retrospective study was performed on 156 consecutive records of patients with a recent history of simple or multiple forefoot amputation. The sample was divided according to Miller's formula into patients at low risk of reulceration and those at high risk; those were further divided into two subgroups according to whether or not the first segment of the forefoot had been amputated. Forty-eight (47·1%) individuals suffered forefoot reulceration, showing a median reulceration-free survival time of 8 months [interquartile range (IR) 3·6-14·8]. Nephropathy (P = 0.005) and Miller's formula (P = 0.028) were risk factors for reulceration-free survival time in the univariate analysis. The pattern relating to the first segment amputated [hazard ratio (HR) 2·853; P = 0·004; 95% confidence interval (CI) 1·391-5·849] and nephropathy (HR 2·468; P = 0.004; 95% CI 1.328-4.587) showed a significant hazard ratio in the multivariate Cox model. Participants with first segment amputation and one other amputation showed an association with the probability of reulceration in comparison with any other specific type of minor amputation., (© 2016 Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Background: There is a high prevalence of non-specific shoulder pain associated with upper limb functional limitations in older adults. The purpose of this study was to determine the minimal clinically important differences (MCID) of grip strength and pressure pain threshold (PPT) in the upper limb between older adults with or without non-specific shoulder pain., Methods: A case-control study was carried out following the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria. A sample of 132 shoulders (mean ± SD years) with ( n  = 66; 76.04 ± 7.58) and without ( n  = 66; 75.05 ± 6.26) non-specific pain were recruited. The grip strength and PPT of the anterior deltoid and extensor carpi radialis brevis (ECRB) muscles were assessed., Results: There were statistically significant differences (mean ± SD; P -value) for anterior deltoid PPT (2.51 ± 0.69 vs 3.68 ± 0.65, kg/cm 2 ; P < .001), ECRB PPT (2.20 ± 0.60 vs 3.35 ± 0.38 kg/cm 2 ; P  < .001) and grip strength (20.78 ± 10.94 vs 24.63 ± 9.38 kg; P = .032) between shoulders with and without non-specific pain, respectively., Discussion: The MCID of 1.17 kg/cm 2 , 1.15 kg/cm 2 and 3.84 kg were proposed for anterior deltoid PPT, ECRB PPT and grip strength, respectively, to assess the upper limb of older adults with non-specific shoulder pain after treatment. In addition, univariate and multivariate (linear regression and regression trees) analyses may be used to consider age distribution, sex, pain intensity, grip strength and PPT in older adults including clinical and epidemiological studies with non-specific shoulder pain., Competing Interests: The authors declare there are no competing interests.

Background: New reliable devices for range of motion (ROM) measures in older adults are necessary to improve knowledge about the functional capability in this population. Dorsiflexion ROM limitation is associated with ankle injuries, foot pain, lower limb disorders, loss of balance, gait control disorders and fall risk in older adults. The aim of the present study was to assess the validity and reliability of the Leg Motion device for measuring ankle dorsiflexion ROM in older adults., Methods: Adescriptive repeated-measures study was designed to test the reliability of Leg Motion in thirty-three healthy elderly patients older than 65 years. The subjects had to meet the following inclusion and exclusion criteria in their medical records: older than 65 years; no lower extremity injury for at least one year prior to evaluation (meniscopathy, or fractures) and any chronic injuries (e.g., osteoarthritis); no previous hip, knee or ankle surgery; no neuropathic alterations and no cognitive conditions (e.g., Alzheimer's disease or dementia). Participants were recruited through the person responsible for the physiotherapist area from a nursing center. The subjects were evaluated in two different sessions at the same time of day, and there was a break of two weeks between sessions. To test the validity of the Leg Motion system, the participants were measured in a weight-bearing lunge position using a classic goniometer with 1° increments, a smartphone with an inclinometer standard app (iPhone 5S ® ) with 1° increments and a measuring tape that could measure 0.1 cm. All testing was performed while the patients were barefoot. The researcher had ten years of experience as a physiotherapist using goniometer, tape measure and inclinometer devices., Results: Mean values and standard deviations were as follows: Leg Motion (right 5.15 ± 3.08; left 5.19 ± 2.98), tape measure (right 5.12 ± 3.08; left 5.12 ± 2.80), goniometer (right 45.87° ± 4.98; left 44.50° ± 5.54) and inclinometer app (right 46.53° ± 4.79; left 45.27° ± 5.19). The paired t -test showed no significant differences between the limbs or between the test and re-test values. The test re-test reliability results for Leg Motion were as follows: the standard error of the measurement ranged from 0.29 to 0.43 cm, the minimal detectable difference ranged from 0.79 to 1.19 cm, and the intraclass correlation coefficients (ICC) values ranged from 0.97 to 0.98., Conclusions: The results of the present study indicated that the Leg Motion device is a valid, reliable, accessible and portable tool as an alternative to the classic weight-bearing lunge test for measuring ankle dorsiflexion ROM in older adults., Competing Interests: The authors declare there are no competing interests.

Metatarsal head resection is a common and standardized treatment used as part of the surgical routine for metatarsal head osteomyelitis. The aim of this study was to define the influence of the amount of the metatarsal resection on the development of reulceration or ulcer recurrence in patients who suffered from plantar foot ulcer and underwent metatarsal surgery. We conducted a prospective study in 35 patients who underwent metatarsal head resection surgery to treat diabetic foot osteomyelitis with no prior history of foot surgeries, and these patients were included in a prospective follow-up over the course of at least 6 months in order to record reulceration or ulcer recurrences. Anteroposterior plain X-rays were taken before and after surgery. We also measured the portion of the metatarsal head that was removed and classified the patients according the resection rate of metatarsal (RRM) in first and second quartiles. We found statistical differences between the median RRM in patients who had an ulcer recurrence and patients without recurrences (21.48 ± 3.10% vs 28.12 ± 10.8%; P = .016). Seventeen (56.7%) patients were classified in the first quartile of RRM, which had an association with ulcer recurrence (P = .032; odds ratio = 1.41; 95% confidence interval = 1.04-1.92). RRM of less than 25% is associated with the development of a recurrence after surgery in the midterm follow-up, and therefore, planning before surgery is undertaken should be considered to avoid postsurgical complications., (© The Author(s) 2015.)

Surgery is usually used to treat diabetic foot osteomyelitis (DFO), whether primarily or in cases in which antibiotics are not able to control infection. In many cases, the bone is only partially removed, which means that residual infection remains in the bone margins, and the wound is left open to heal by secondary intent. The use of culture-guided postoperative antibiotic treatment and adequate management of the wound must be addressed. No trials exist dealing with local treatment in the postoperative management of these cases of complicated DFO. We decided to test a super-oxidized solution, Dermacyn Wound Care (DWC; Oculus Innovative Sciences Netherlands BV, Sittard, Netherlands) to obtain preliminary experience in patients in whom infected bone remained in the surgical wounds. Our hypothesis was that DWC could be useful to control infection in the residual infected bone and surrounding soft tissues and would thus facilitate healing. Fourteen consecutive patients who underwent conservative surgery for DFO, in whom clean bone margins could not be assured, were treated in the postoperative period with DWC. Eleven cases were located in the forefoot, 6 on the first ray and the rest in lesser toes, 1 in the Lisfranc joint, and 2 on the calcaneus. No side effects appeared during treatment. Neither allergies nor skin dermatitis were found. Limb salvage was successfully achieved in 100% of the cases. Healing was achieved in a median period of 6.8 weeks.