πŸ›οΈ Verified NIH Record β€’ Updated 2025-05-27

Sterilised, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers (NCT05687656)

A Prospective, Multi-center Observational Study to Investigate the Safety and Effectiveness of Sterilized, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers

πŸ”΅ Active, Not Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: ConvaTec Inc.

🩺 Plain-English Summary (8th-Grade Level)

A Prospective, Non-Randomized, Multi-Center Observational Study To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs) Eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading

Who can join: Review the eligibility criteria below.

Location: Three Rivers Hyperbaric and Wound Center β€” North Port, Florida

Age range: 18 Years

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

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

πŸ“ All Participating Trial Locations (5 Sites)

  • Three Rivers Hyperbaric and Wound Center β€” North Port, Florida
  • Serena Group Buffalo Research Center β€” Buffalo, New York
  • SerenaGroup Monroeville β€” Monroeville, Pennsylvania
  • SerenaGroup Austin Research Center β€” Austin, Texas
  • Atrium Medical Center β€” Stafford, Texas

πŸ’° 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 Β§ 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.

πŸ’‘ 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.
πŸ›οΈ View Official NIH Record β†—