🏛️ 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 Checklist

Full 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.

Explore by condition: All Diabetic Foot clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗