Study of Concurrent Optical and Magnetic Stimulation COMS Plus Standard Care Versus Standard Care Alone for Healing Chronic Venous Leg Ulcers and Related Vascular Ulcers

What this Trial Is About

Chronic leg and foot ulcers are wounds that do not heal properly over 4 to 8 weeks despite standard care, often due to vascular problems like chronic venous insufficiency and peripheral artery disease. These conditions reduce blood flow, limiting oxygen and nutrients needed for healing, and cause ongoing inflammation and infection. This trial evaluates a new combined optical and magnetic stimulation COMS therapy alongside standard care to improve healing, pain, quality of life, and economic outcomes for patients with venous leg ulcers, including those with arterial complications. Participants will be randomly assigned to receive either standard care alone or standard care plus COMS therapy. Standard care includes wound cleaning, dressing changes, debridement, analgesics as needed, and compression therapy according to guidelines. The COMS treatment is applied 2 to 3 times per week for at least 8 weeks using a specialized device during standard care procedures. If patients receive care at home, trained caregivers will perform these treatments. During the 24-week study, participants will have regular assessments to monitor wound healing, pain, quality of life, and ulcer recurrence. Researchers will measure the percent reduction in wound area as the primary outcome after 24 weeks, along with complete wound closure and time to healing. Safety and device usability will also be evaluated. The study is single-blinded with data assessors unaware of group assignments and includes multiple clinical sites across several countries.

COMS for Chronic Ulcers Treatment