Study of the COMS One Device to Treat Long-Lasting Diabetic Foot Ulcers in Adults Aged 22 to 90

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the COMS One device in treating people with refractory diabetic foot ulcers DFUs. This prospective randomized, double-blinded, sham-controlled clinical trial aims to show that the COMS One device, used alongside standard care, can better promote wound closure compared to a sham device over 24 weeks. The main goal is to measure the time until complete wound healing, defined by full skin re-epithelialization without drainage. The study involves two groups one receiving the COMS One device and the other a sham device. Both devices include a reusable housing with controls and magnetic stimulation coils, a single-use sterile base called COMStouch, and a single-use strap called COMSfix to hold the device in place. Treatments are applied locally and participants continue standard wound care. The study plans to enroll 224 subjects after screening up to 450, with treatments lasting up to 24 weeks. Participants will attend regular visits to assess wound healing progress, safety, pain levels, and quality of life. Researchers will measure wound closure at multiple timepoints up to 24 weeks and monitor for adverse events, ulcer recurrence, and any need for amputation. The study includes careful monitoring of wound area reduction and participant-reported outcomes to evaluate the devices performance and safety throughout the trial.

Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers