A Novel Classification for Diabetic Foot Ulcers of the First Ray.

OBJECTIVE: Diabetic foot ulcers of the first ray result from several distinct biomechanical mechanisms related to anatomical deformities, which must be addressed if surgical offloading is contemplated. The objective of this study was to create a classification of the anatomical deformities of first-ray ulcers that could lead to better standardization of treatment and reporting. METHODS: The authors performed a file review of patients with diabetic neuropathy diagnosed with first-ray ulcers over a period of 3 years in an outpatient setting. Anatomical deformities were diagnosed clinically and reported with ulcer location. The primary classification was the metatarsophalangeal joint, the interphalangeal joint, and the distal phalanx. RESULTS: Records for 59 patients (mean age, 62 years) with University of Texas A1 and A2 ulcers were reviewed. Mean ulcer duration was 2 months. The more common deformities were hallux valgus (41%), hallux valgus interphalangeus (14%), and hallux malleus (20%), and these were primarily associated with metatarsophalangeal, interphalangeal joint, and tip-of-toe ulcers, respectively (P < .0001). CONCLUSIONS: By classifying ulcer locations, the relevant corrective surgery may be chosen. Although some prophylactic procedures may be safe and effective, prophylactic hallux valgus correction in the diabetic foot requires further study.

Telemedicine versus face-to-face care for treatment of patients with lower extremity ulcers.

OBJECTIVE: Lower extremity ulcers (LEUs) are associated with a decline in patients' quality of life (QoL). Better healthcare availability in remote regions, facilitated by telemedicine (TM), may improve patient wellbeing. The aim of this study was to compare the QoL of patients treated via synchronous video TM with that of patients treated with standard face-to-face (FTF) care. METHOD: The study was performed in a large health services provider in Israel (Maccabi Healthcare Services). TM was used in four remote locations; the FTF method was applied in two regional clinics. The treatment protocol was performed by a nurse and supervised by the regional physician in both treatment modes. A validated Wound-QoL questionnaire in Hebrew was used to assess patient outcomes. RESULTS: A total of 83 patients were treated via TM and 94 patients were treated FTF. The mean QoL for patients treated via TM was 0.546±0.249 compared with 0.507±0.238 for the FTF group. A similarity relating to outcomes in both treatment methods was demonstrated by a difference of 0.039 (95% confidence interval -0.33-0.111) and p=0.291. The probability of the difference being within the limits of the interval in a replicated study was 83.4%. The equivalence/non-inferiority was established within the accepted Δ=0.12 range. CONCLUSION: The results indicated no reduced QoL for patients with LEUs treated with telemedicine versus with standard FTF care. DECLARATION OF INTEREST: The authors have no conflicts of interest.

Remote Care of Lower Extremities Ulcers: An Observational Pilot Study.

BACKGROUND: Lower extremities ulcers (LEU) are associated with considerable morbidity and mortality. With longer life expectancy, the prevalence of LEU in developed countries is assumed to grow, necessitating an increased demand for treatment by specialists. OBJECTIVES: To compare the effectiveness of a telemedicine video conferencing modality with the conventional face-to-face treatment of LEU. METHODS: The study was conducted in conjunction with a two-million member healthcare organization in Israel (Maccabi Healthcare Services). Consecutive visits of patients to wound care specialists during a 12-month observation period reviewed in 2015 were valuated. A nurse-assisted setting was implemented during all treatment sessions. The same specialist supervised patients in both modalities. RESULTS: A sample of 111 patients (n=55 in the telemedicine group; n=56 in the face-to-face group) with 593 visits was analyzed. No significant difference in healing of LEU (78.2% in telemedicine vs. 75.0% in face-to-face) was detected, P = 0.823. A reduced number of visits in telemedicine (4.36 ± 2.36) compared to the face-to-face care (6.32 ± 4.17) was shown, P = 0.003. Non-inferiority of telemedicine demonstrated within the Δ = 15% range limits and 80% statistical power was demonstrated. CONCLUSIONS: Compared to the usual face-to-face method, synchronous video conferencing-based telemedicine may be a feasible and efficient method for LEU management.

Synchronous video telemedicine in lower extremities ulcers treatment: A real-world data study.

INTRODUCTION: With growing prevalence of lower extremity ulcers (LEU) and shortage of wound specialists, gaps in access to care may occur, particularly in remote areas. This gap can be mitigated with high-quality telemedicine (TM). This study aims to explore the effectiveness of synchronous video TM compared to the conventional face-to-face treatment (FTF). METHODS: The study was conducted at Maccabi Healthcare Services, a 2.2-million-member sick fund in Israel. We reviewed all consecutive visits of LEU patients to wound care specialists between Jan 2013 and Jun 2017. Both TM and FTF modalities were implemented using identical treatment settings with the same nurse at each location. Study endpoint was ulcer healing as assessed by the treating specialist. RESULTS: The study population included 650 LEU cases (nTM = 277, nFTF = 373) and contained 5203 visits. Comparable (P = 0.475) proportions of healed ulcers (52% in TM vs. 55% in FTF) were detected. Survival analyses found a non-significant advantage of TM (0.887; 0.650-1.212) compared to FTF. The non-inferiority of TM was demonstrated within the Δ = 0.15 range limits and 80% statistical power. Trial replication probability is 0.93. CONCLUSIONS: Synchronous video-conferencing based telemedicine may be a feasible and efficient method of LEU management.

A Novel Recombinant Human Collagen-based Flowable Matrix for Chronic Lower Limb Wound Management: First Results of a Clinical Trial.

BACKGROUND: Chronic ulcers pose a significant health concern and economic burden. Numerous products, including animal-derived collagen products, have been designed to provide the injured site with a biocompatible structural matrix that promotes tissue regeneration. Yet, animal-derived collagens can evoke immune responses, bear risk of disease transmission, and fail to closely mimic the function of native collagen. OBJECTIVE: This study aims to assess the safety and performance of a novel flowable wound matrix, formulated from tobacco plant-purified fibrillated recombinant human type I collagen (rhCollagen), in patients with chronic lower limb ulcers. MATERIALS AND METHODS: This single-arm, open-label, multicenter trial took place at 5 treatment centers. Wounds were photographed and preliminary surgical debridement was performed prior to rhCollagen application. Patients received a single application of rhCollagen to the wound bed, followed by weekly assessments of the wound. RESULTS: Twenty patients (mean age, 63 years), presenting with a chronic ulcer of neuropathic (45%), posttraumatic (35%), postoperative (10%), and venous (10%) origin, underwent rhCollagen treatment. Initial wound area ranged between 0.2 cm3 to 9.2 cm3. At 4-weeks posttreatment, median wound area reduction was 94%. Fifteen ulcers exhibited ≥ 70% wound closure, 9 of which achieved complete closure. Only 1 participant suffered a local self-resolving wound infection. No significant device-related adverse events were reported throughout the study. CONCLUSIONS: A single, easy-to-use rhCollagen flowable gel application for chronic lower limb ulcers may promote wound closure with minimal adverse events.

Topical oxygen therapy stimulates healing in difficult, chronic wounds: a tertiary centre experience.

OBJECTIVE: Oxygen plays a central role in wound healing. Recent technological advances have miniaturised oxygen delivery systems, with novel topical oxygen therapy allowing patients to receive oxygen therapy 24 hours a day while remaining completely mobile. Here we aim to examine the efficacy and safety of continuous topical oxygen diffusion in a 'real-world' setting. METHODS: Topical oxygen therapy (TOT) was evaluated in patients with chronic, non-healing wounds in a tertiary referral specialist clinic. RESULTS: The mean wound duration before TOT was 15 months. Regardless of treatment duration, in this previously non-healing group complete wound closure was observed in 32% of the total patients treated with the TOT device. However, optimal wound healing occurred when the device was used for >25 days, with an 83% wound area reduction and 47% wound closure rate seen in venous leg ulcers (VLUs) and a 74% reduction and a 57% wound closure rate in arterial foot ulcers. CONCLUSION: Use of TOT in chronic wounds stimulates a healing state. In our study, almost half of the previously non-healing wounds closed.

Validation of "Wound QoL" Hebrew version disease-specific questionnaire for patients with lower extremity ulcerations.

The slow healing process and high recurrence rate of lower extremity ulcerations (LEU) impose a considerable medical and economic burden and affect quality of life (QoL). Analyses of LEU-related QoL in Israel are limited due to lack of a validated Hebrew disease-specific evaluation instrument. The aim of this study was to validate the disease-specific Hebrew "Wound QoL" questionnaire. The validation of the "Wound QoL" disease-specific instrument, translated from English to Hebrew, was based on a comparison with the valid Hebrew version of the SF12v.2 health-related questionnaire. The convenience sample for the "Wound QoL" validation (n = 32) was obtained from patient populations in the Maccabi Health Services' outpatient clinics at the northern and southern parts of Israel. The study was conducted between June and September 2017. Face/construct validity was accepted by specialists' consensus. Internal consistency assessed by Cronbach's α was .893. Concurrent validity reflected by Pearson's correlations between the tools was in the range of 0.830 to 0.950. The Wound QoL Hebrew version is a valid and reliable instrument suitable for implementation in an Israeli cultural environment.

Assessment of IL-1ß and VEGF concentration in a rat model during orthodontic tooth movement and extracorporeal shock wave therapy.

OBJECTIVE: This study aimed to investigate PDL's cytokine concentration fluctuations after induction of orthodontic force with and without extracorporeal shock wave therapy in a rat model. MATERIALS AND METHODS: An orthodontic appliance was fabricated and applied between the molars and the incisors of rats. The rats were treated by a single episode of 1000 shock waves and gingival crevicular fluid was collected for 3 days. The expression and concentration of IL-1ß and VEGF were evaluated by ELISA assay. On day 3 all rats were sacrificed and histologic and immunohistochemical assays were applied. RESULTS: IL-1ß concentration rose in both the treated and non treated shockwave groups on the first day, however it was statistically significantly higher in the treated group on day 2. No statistically significant difference was detected between the groups on day 3. The number/area of TRAP positive cells was higher in the non shockwave group than in the treated group. The percentage of cells expressing VEGF displayed the opposite trend. The findings regarding the immunohistochemical assay for IL-1ß corresponded with those of the ELISA assay on day 3. CONCLUSION: The application of shockwaves during orthodontic tooth movement influences the expression of IL-1ß and VEGF and may alternate the periodontal remodelling expected rate.

Adult (somatic) stem cells and the musculoskeletal system.

Stem cells offer a glimpse into a future that might unravel the promising ability of wide-ranging biological reconstructions.

Minimally invasive surgical techniques for the reconstruction of calcaneal fractures.

The soft tissues play a crucial part in both the stabilization of the multiple joint surfaces of the calcaneus and in allowing propulsion as needed. Therefore, minimally invasive functional stabilization of heel bone fracture is a promising technique, which may bypass all published controversies. Experience has shown that ligamentotaxis, which means the use of mechanical forces applied to the soft-tissue envelope of fractures without the surgical disruption of the latter, contributes to fracture healing and reconstruction. Therefore, based on our results, minimally invasive techniques are useful and promising in calcaneal fracture treatment.