๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-15

EDX110 Randomized Control Trial for Treatment of DFUs (NCT07209358)

A Multi-Centre, Observer-Blinded, Randomized Controlled Trial of EDX110 for the Treatment of Diabetic Foot Ulcers

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

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

Prospective, multi-centered, observer blinded, pre-market study, 1:1 randomized control trial, to determine if addition of EDX110 dressing system to standard of care leads to an improvement in diabetic foot ulcers healing compared to just using standard of care.

Who can join: Review the eligibility criteria below.

Location: Axentra Bio โ€” Phoenix, Arizona

Age range: 18 Years to 90 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 (4 Sites)

  • Axentra Bio โ€” Phoenix, Arizona
  • Clemente Clinical Research โ€” Santa Ana, California
  • ILD Research Center โ€” Vista, California
  • Futuro Clinical Trials โ€” McAllen, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (260) 418-9196

Email: andrea.picchietti@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.

Explore by condition: All Wound Heal clinical trials

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†—