Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy (NCT07086443)
A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating Placental Derived Allografts and Standard of Care in the Treatment of Nonhealing Diabetic Foot Ulcers Using Matched Controls
🩺 Plain-English Summary (8th-Grade Level)
The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.
Who can join: Review the eligibility criteria below.
Location: Serena Group- Monroeville — Monroeville, Pennsylvania
Age range: 18 Years
🧪 Interventions in This Study
- Activate™ Matrix (OTHER)
- AmnioDefend™ FT Matrix (OTHER)
- Palisade™ DM Matrix (OTHER)
- Enclose™ TL Matrix (OTHER)
- Sentry™ SL Matrix (OTHER)
- Shelter™ DM Matrix + SOC (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Serena Group- Monroeville — Monroeville, Pennsylvania
📞 Contact the Study Coordinator
Phone: (833) 865-6300
Email: info@serenagroups.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
More studies in Diabetic Foot Ulcer
- Omega3 Wound Fish Skin Graft in the Treatment of DFUs — Coconut Creek, Florida
- At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers — Baltimore, Maryland
- A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot — San Francisco, California
- Efficacy of ProgenaMatrix™ in the Management of DFUs — Puyallup, Washington
- Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management — Palm Springs, California
- NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers — Phoenix, Arizona
Explore by condition: All Diabetic Foot Ulcer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.