Plain-English translation of NCT07852338 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This study is testing BIOxHEAL, a treatment made from placental tissue, to see if it helps heal stubborn diabetic foot ulcers better than standard wound care alone. About 253 people with diabetes and non-healing foot sores will participate across 30 centers in the United States. Some participants will receive the medication plus standard care, while others will receive standard care by itself, so researchers can compare how well each approach works.
Diabetic foot ulcers are a serious complication that can be slow to heal and lead to serious infections or amputation. This trial exists to find out whether this new placental tissue-based treatment can help wounds heal faster and more reliably than current standard care alone.
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If you enroll, you will attend weekly clinic visits for up to 12 weeks or until your ulcer closes completely. At each visit, you'll receive either the placental tissue treatment plus standard wound care, or standard care alone (depending on which group you're assigned to). The treatment is applied to the ulcer once a week, and you'll need to continue using the prescribed offloading method (a special shoe or device that reduces pressure on the wound) throughout the study. After your wound heals, you'll have follow-up visits for 3 months to make sure it stays closed.
AI-generated summary from trial data · Oct 5, 2026 · Not medical advice
United States