🏛️ Verified NIH Record • Updated 2025-07-08
SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II) (NCT06140303)
Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers. Closure Obtained With Vascularized Epithelial Regeneration for DFUs With SkinTE® II (COVER DFUS II)
🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: PolarityTE
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.
Who can join: Review the eligibility criteria below.
Location: Titan Clinical Research — Mesa, Arizona
Age range: 18 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 (23 Sites)
- Titan Clinical Research — Mesa, Arizona
- Center for Clinical Research — Castro Valley, California
- Limb Preservation Platform, Inc. — Fresno, California
- Angel City Research — Los Angeles, California
- Clemente Clinical Research Inc. — Los Angeles, California
- Center for Clinical Research — San Francisco, California
- Clemente Clinical Research Inc. — Santa Ana, California
- ILD Research — Vista, California
- Las Mercedes Medical Research, Inc. — Hialeah, Florida
- Doctors Research Network — Miami, Florida
- DMI Research — Pinellas Park, Florida
- Barry University Clinical Research — Tamarac, Florida
- FASMA - Hagerstown — Hagerstown, Maryland
- Viable Research Management — Henderson, Nevada
- Northwell Health, Inc. — New Hyde Park, New York
- Mount Sinai West Hospital — New York, New York
- LEIRT (Lower Extremity Institute for Research and Therapy) — Boardman, Ohio
- Cutting Edge Research LLC — Circleville, Ohio
- LEIRT (Lower Extremity Institute for Research and Therapy) — East Liverpool, Ohio
- Cutting Edge Research LLC — Grove City, Ohio
- Perfizien Clinical Research LLC. — Houston, Texas
- Baylor Scott & White Health — Plano, Texas
- Foot and Ankle Specialists of the Mid-Atlantic — Salem, Virginia
💰 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.
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- Effectiveness of Remote Foot Temperature Monitoring — Hines, Illinois
- A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers — Hollywood, Florida
- Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers — Thousand Oaks, California
- Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers — Downey, California
Explore by condition: All Diabetic Foot clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.