CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations (NCT07046767)
A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Tri- Layer Amnion Graft or a Single Layer Amnion Graft to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-to-heal DFUs and VLUs
🩺 Plain-English Summary (8th-Grade Level)
CAMP RWE Trial: A Multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs
Who can join: Review the eligibility criteria below.
Location: FOMAT Medical Research — Oxnard, California
Age range: 18 Years
🧪 Interventions in This Study
- IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap (OTHER)
- IP2: BioLab Tri-Membrane Wrap (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 (7 Sites)
- FOMAT Medical Research — Oxnard, California
- Solutions Medical Research — Coral Gables, Florida
- Nova Medical Services - Research Division LLC — Miami, Florida
- Indiana University Health Methodist Hospital — Indianapolis, Indiana
- St. Louis Foot and Ankle, LLC — St Louis, Missouri
- Jevlos Health, Inc — Syosset, New York
- Hope Vascular and Podiatry — Houston, Texas
📞 Contact the Study Coordinator
Phone: (512) 571-2966
Email: mdocter@capsicure.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
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.