Device treatment for diabetic foot ulcers with poor blood flow
Part of Heart & circulation, Hormones & metabolism, Skin clinical trials.
This trial tests whether COMS One is safe and effective for healing a specific diabetic foot ulcer. It may help people whose ulcer is not healing well, especially when blood flow to the foot is limited.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You’re 22 to 90 years old, and you have Type 1 or Type 2 diabetes
- You have one target diabetic foot ulcer that goes through the skin but has no exposed bone (Wagner Grade 1–2)
- The ulcer is on or below the ankle bones, and it’s been there more than 30 days but less than 52 weeks
- The ulcer area is between about 0.5 and 25 square centimeters after debridement (removing dead tissue)
- Your foot has enough blood flow for wound healing based on a test like skin perfusion, ankle/toe blood pressure, or toe oxygen; or specific index/pressure thresholds
- If you can get pregnant: you must use reliable birth control during the study; and you must be able to understand consent and follow visit/wound-care rules
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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