Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers (NCT05758545)
Concurrent Optical and Magnetic Stimulation (COMS) for Treatment of Refractory Diabetic Foot Ulcer; a Prospective Randomized, Sham-controlled, Double-blinded, Pivotal Clinical Trial
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to demonstrate superiority of wound closure of the COMS One device to a sham-control device through 24 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs.
Who can join: Review the eligibility criteria below.
Location: Titan Clinical Research — Mesa, Arizona
Age range: 22 Years to 90 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (30 Sites)
Showing the first 25 of 30 sites.
- Titan Clinical Research — Mesa, Arizona
- Southern Arizona VA Health Care System — Tucson, Arizona
- Center for Clinical Research Inc. — Castro Valley, California
- VA Central California Healthcare — Fresno, California
- Limb Preservation Platform, Inc. — Fresno, California
- Angel City Research, Inc. — Los Angeles, California
- UCLA Ronald Regan - Department of Surgery — Los Angeles, California
- Center for Clinical Research Inc. — San Francisco, California
- Center for Clinical Research Inc. — San Francisco, California
- ILD Research Center — Vista, California
- Bay Pines VA Healthcare System — Bay Pines, Florida
- MCR Health — Bradenton, Florida
- University of Florida Health Jacksonville — Jacksonville, Florida
- Clever Medical Research LLC — Miami, Florida
- The Angel Medical Research Corporation — Miami Lakes, Florida
- Vital Medical Research — Sweetwater, Florida
- Aiyan Diabetes Center — Augusta, Georgia
- Northwestern University Feinberg School of Medicine — Chicago, Illinois
- Rush University — Chicago, Illinois
- Gateway Clinical Trials — O'Fallon, Illinois
- Curalta Clinical Trials — Westwood, New Jersey
- Veteran Affairs of WNY Healthcare System — Buffalo, New York
- Northwell Comprehensive Wound Healing Center — Lake Success, New York
- UNC Medical Center — Chapel Hill, North Carolina
- The Ohio State University — Columbus, Ohio
📞 Contact the Study Coordinator
Phone: +41 44 244 19 78
Email: williams@piomic.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Diabetic Foot Ulcer
- Omega3 Wound Fish Skin Graft in the Treatment of DFUs — Coconut Creek, Florida
- At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers — Baltimore, Maryland
- A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot — San Francisco, California
- Efficacy of ProgenaMatrix™ in the Management of DFUs — Puyallup, Washington
- Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management — Palm Springs, California
- NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers — Phoenix, Arizona
Explore by condition: All Diabetic Foot Ulcer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.