๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-07

IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers (NCT06616844)

Evaluating the Efficacy of Porcine Placental Extracellular Matrix Augmented Wound Care Against Standard Wound Care for the Management of Diabetic Foot Ulcers: A Multi-center, Prospective, Observer-blinded, Randomized Controlled Clinical Trial.

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: ConvaTec Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers.

Who can join: Review the eligibility criteria below.

Location: Limb Preservation Platform โ€” Fresno, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (21 Sites)

  • Limb Preservation Platform โ€” Fresno, California
  • Angel City Research โ€” Los Angeles, California
  • Clemente Clinical Research โ€” Los Angeles, California
  • Valiance Clinical Research โ€” San Diego, California
  • Center for Clinical Research โ€” San Francisco, California
  • Valiance Clinical Research โ€” Tarzana, California
  • ILD Research Center โ€” Vista, California
  • First Excellence Research Group โ€” Doral, Florida
  • White-Wilson Wound Care Center โ€” Fort Walton Beach, Florida
  • Dinamo Research and Diagnostic Center โ€” Hialeah, Florida
  • University of Florida Jacksonville โ€” Jacksonville, Florida
  • Sunshine Ankle and Foot Experts โ€” Orlando, Florida
  • Lenus Research and Medical Group, LLC โ€” Sweetwater, Florida
  • Indiana Foot & Ankle โ€” Jasper, Indiana
  • US-FAS โ€” Hagerstown, Maryland
  • Boston Medical Center โ€” Boston, Massachusetts
  • Northwell Health Comprehensive Wound Healing Center โ€” New Hyde Park, New York
  • US-FAS โ€” Raleigh, North Carolina
  • University of Pittsburgh Medical Center (UMPC) โ€” McKeesport, Pennsylvania
  • Innovative Medical Research of Texas โ€” Houston, Texas
  • New Dawn Wellness and Medical Research Center โ€” Houston, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: 07767036374

Email: andrew.thomas@convatec.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ 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 ยง 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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๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  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.
๐Ÿ›๏ธ View Official NIH Record โ†—