🏛️ Verified NIH Record • Updated 2026-08-19

PREPUP: A Randomized Trial of Bonvadis® Versus Collagenase Ointment in Diabetic Foot Ulcers (NCT07779239)

A Prospective, Multicenter, Multi-Product, Comparative Effectiveness, Randomized Controlled Clinical Trial Evaluating a Novel Wound Bed Optimization Technology (NWBOT) and Standard of Care (SOC) Versus Clostridial Collagenase Ointment (CCO) Plus SOC in Diabetic Foot Ulcers, With Matched-Control Comparison to Topical Hydrogel and Comparisons to Synthetic Standard-of-Care and Topical Collagen Comparator Cohorts.

🟡 Not Yet Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Oneness Biotech Co., Ltd.

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

This study is designed to evaluate topical wound products for DFUs using a hybrid design that combines prospectively randomized treatment arms with external control cohorts.

Who can join: Review the eligibility criteria below.

Location: Site #4 — North Port, Florida

Age range: 18 Years

📋 "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 (10 Sites)

  • Site #4 — North Port, Florida
  • Site #3 — Palm Coast, Florida
  • Site #6 — South Miami, Florida
  • Site #2 — Metairie, Louisiana
  • Site #8 — Brooklyn, New York
  • Site #7 — Akron, Ohio
  • Site #10 — Circleville, Ohio
  • Site #9 — Tulsa, Oklahoma
  • Site #1 — Monroeville, Pennsylvania
  • Site #5 — Philadelphia, Pennsylvania

💰 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.

💡 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 ↗