COMS One Device for Diabetic Foot Ulcers
This study is testing a device called COMS One for people with diabetic foot ulcers (DFUs) that haven't healed well. The COMS One device uses light and magnetic stimulation. Researchers want to see if it's safe and helps wounds heal better than a sham device (a device that looks real but doesn't have the active treatment). You could be eligible if you are between 22 and 90 years old and have a DFU. The main goal is to see if your wound completely heals within 24 weeks after starting treatment. The study is currently recruiting 450 participants, but its exact status is unclear.
- Study design
- This is a randomized, double-blinded, sham-controlled study with 450 planned participants. This means you would be randomly assigned to receive either the COMS One device or a sham device, and neither you nor your doctors would know which one you are receiving.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main goal is to measure complete wound healing at 24 weeks post-application of the device.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers
At a glance
Conditions
Where it's being run
30 sites across 12 statesStudy leadership
- Aksone Nouvong, DPM · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles
Who to contact
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What this trial measures
- Complete wound healing24 weeks post-application
The primary endpoint for this pivotal trial is time to complete wound closure from randomization through 24 weeks, which is defined as complete skin re-epithelialization without drainage confirmed by 2 consecutive trial visits 2 weeks apart.