Clinical Research Directory

Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers

Chronic lower limb ulcers, particularly those of venous etiology, are difficult-to-heal wounds that severely affect patients' quality of life. Adequate tissue oxygenation is essential for wound healing. This study investigates the effects of vacuum compression therapy (VCT) on local tissue oxygenation and wound healing in patients with chronic venous lower limb ulcers. Patients will be randomly divided into two groups: an experimental group receiving VCT alongside standard wound care, and a control group receiving standard wound care alone. The main goal is to compare tissue oxygen levels between the treated (diseased) leg and the untreated (healthy) leg, as well as between the two patient groups before and after therapy. Researchers will also closely monitor how the wounds heal over time using standard clinical measurements and advanced digital photograph analysis (Fiji software). The findings will help determine if VCT specifically increases oxygenation in the treated limb and accelerates wound closure compared to standard care.

Modified Platform Trial Assessing Multiple Umbilical Cord-based CAMPs and SOC v SOC Alone in the Treatment of Hard-to-Heal VLUs

The purpose of this study is to evaluate the efficacy of two dehydrated human umbilical cord-based medical devices, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal venous leg ulcers over 12 weeks using a modified platform trial design.

Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers

The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers.

Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care

Venous leg ulcer is the final stage of chronic venous disease and only develops due to advanced chronic venous insufficiency. The problems caused by venous disease are initially minor and often neglected, but can impact the quality of life of patients. The prevalence of leg ulcers is estimated at 1% of the general population and 3% to 5% of subjects over 65 years old. Its prevalence increases with age in both men and women. Managing chronic ulcers requires a certain number of care procedures, including debridement. The act of treatment by mechanical debridement is little relieved by the analgesics given beforehand, and can be painful, with risks of bleeding. Musicotherapy, particularly the U-shaped method, has shown its effectiveness in the treatment of pain and anxiety in several areas (geriatrics, intensive care, rheumatology, oncology, etc.). The standardized musicotherapy method of the U-shaped sequence was developed and initially evaluated by clinical studies coordinated by the INSERM unit U1061 (Pr. Jacques Touchon; Dr. Stéphane Guétin). Following the publication of numerous controlled, randomized studies presenting results on the effectiveness in the treatment of pain and anxiety, a digital application was developed in order to standardize the method. The Music Care health application is now a Class 1 Medical Device, with CE marking obtained. This "U-shaped sequence" is standardized and has been clinically validated, which makes Music Care a unique tool available for pain relief. No studies have been found in the literature regarding the use of music therapy during debridement care.