Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers. (NCT07209475)
A Randomized Controlled Multicenter Trial, Examining the Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
🩺 Plain-English Summary (8th-Grade Level)
This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). The study will evaluate Amnio-Maxx® Dual Layer Amnion Patch.
Who can join: Review the eligibility criteria below.
Location: Lion Heart Clinical Research — Burbank, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "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 (8 Sites)
- Lion Heart Clinical Research — Burbank, California
- Royal Research South — Miami, Florida
- Denali Health Atlanta, LLC — Stone Mountain, Georgia
- SerenaGroup Research Center — Omaha, Nebraska
- Suffolk Foot and Ankle — East Patchogue, New York
- Wound Care of Tulsa — Tulsa, Oklahoma
- VAST Clinical Research Carrollton Foot Center — Carrollton, Texas
- Elite Foot & Ankle Associates — Spicewood, Texas
📞 Contact the Study Coordinator
Phone: (724) 664-3843
Email: nschrecengost@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 (DFU)
- Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU — Colorado Springs, Colorado
- Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers — North Port, Florida
- HEAL-4: Real-World Effectiveness of 4 Amniotic Allografts Adjunctive to Standard Care in DFU, VLU, and PU — Novi, Michigan
- Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing — Chicago, Illinois
- Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers — Hollywood, Florida
- CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations — Oxnard, California
Explore by condition: All Diabetic Foot Ulcer (DFU) 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.