Malestroit

Chronic leg and foot ulcers are wounds that do not heal properly over several weeks, often due to blood flow problems caused by conditions like chronic venous insufficiency or peripheral artery disease. These ulcers share biological challenges such as reduced oxygen and nutrient supply, leading to impaired cell functions, persistent inflammation, and infections that prevent healing. Standard treatments include compression therapy, physical activity, and surgical procedures to improve blood flow and support wound repair. This trial evaluates a combined treatment called Concurrent Optical and Magnetic Stimulation (COMS) alongside standard care, compared to standard care alone, in patients with venous leg ulcers or venous leg ulcers with peripheral artery disease. COMS therapy uses magnetic stimulation and light therapy to activate cellular processes that promote healing, such as increased energy production, cell growth, blood vessel dilation, and reduced inflammation. Patients in the intervention group receive COMS treatment 2-3 times weekly for at least 8 weeks, with a minimum of 16 sessions, during their usual wound care procedures. Participants will be followed for a total of 24 weeks. During this time, researchers will monitor wound healing progress, including the percent reduction in wound area at 24 weeks. Assessments include wound evaluations, quality of life measures, pain levels, and device usability. The study is conducted across multiple centers in several European countries, with treatments and follow-up occurring in outpatient or home care settings. Safety and effectiveness data will be analyzed to understand the impact of COMS therapy on chronic vascular ulcers.