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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.

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.)

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.)

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 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.

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.

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 describe the outcomes of a new product based on negatively charged polystyrene microspheres (NCM) technology, in non-responding diabetic foot ulcers (DFU)., Methods: A clinical case series of patients with a hard-to-heal DFU treated with NCM were recruited between March and June 2017 in a specialised diabetic foot unit. DFUs were treated daily with NCM over four weeks, although the health professional could decide to continue NCM treatment in some patients. Cases were followed up for 12 weeks. Wollina score (granulation, colour and consistency tissue), wound area (cm 2 ), percentage reduction and wound closure (%) were measured., Results: A total of 22 ulcers (19 patients) were included, of which three patients (five ulcers) were withdrawn due to adverse events: four infections and one necrosis. None were associated with the product. NCM treatment was completed in 17 ulcers (16 patients). The mean patient age was 61.53±9.57 years. At baseline, mean duration time of the DFU was 7.88±8.65 weeks, the median area was 5.35cm 2 , the interquartile range (IQR) was 1.45 to 4.65cm 2 and positive probe-to-bone test (PTB+) was recorded at 29.4%. After four weeks of treatment, an increase in Wollina score (3.65±2.12 to 5.69±1.18; p=0.000), a 62.2% reduction of the ulcer area (5.35 cm 2 ; IQR: 1.45 to 4.65cm 2 ) to 3.33cm 2 (IQR: 0.25 to 1.70cm 2 ; p<0.001) and complete healing in 17.6% of ulcers was observed. The mean time of NCM treatment was 6.2±1.2 weeks. At 12 weeks, 100% achieved complete healing, including those ulcers with PTB+., Conclusion: After NCM use, a reactivation of the healing process in non-responding wounds was observed, having a significant improvement in Wollina score as well as reduction of the wounds. Complete healing was achieved in all ulcers at 12 weeks, including PTB+.

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.)

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.)

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.

Aims: The aim is to define the association of forefoot deformity and limited joint mobility in the ankle and hallux joints in patients with diabetes mellitus subject to different diagnostic tests for diabetic neuropathy. Prospective study with 118 type 2 diabetic patients (68 men, mean age of 65.6±9.9 years) enrolled consecutively from the Diabetic Foot Unit of the Complutense University of Madrid subject to evaluation of plantar surface sensitivity by 10-g Semmes-Weinstein Monofilament, vibratory threshold by biothesiometer, and sudomotor dysfunction by Neuropad®. The patients presented with limited joint mobility of the ankle and the first metatarsophalangeal joints, and forefoot deformities were registered. Statistical analysis was done through a univariate model to test the association between neurological and biomechanical alteration. There was an association of abnormal Monofilament (p=0.01; OR=3.9) and biothesiometer tests (p=0.01; OR=2.6) with the presence of forefoot deformity. Furthermore, a relation was found between abnormal Monofilament (p=0.02; OR=4.8) and biothesiometer (p<0.00; OR=12.8) tests with limited mobility of the first metatarsophalangeal joint both in loading and off-loading. Abnormal sudomotor function test was related with limited joint mobility of the ankle joint with the knee flexed (p=0.04; OR=2.8)., Conclusions: The results of this study show discordance between biomechanical abnormalities and neuropathy depending on the diagnostic test used. Tests that assess large myelinated nerve fibers are associated with the presence of deformities. Abnormal sudomotor function test is associated with limited joint mobility and this test has a greater capacity for selecting patients at risk., (© J. A. Barth Verlag in Georg Thieme Verlag KG Stuttgart · New York.)