HEAL-4: Real-World Effectiveness of 4 Amniotic Allografts Adjunctive to Standard Care in DFU, VLU, and PU (NCT07223515)
Effectiveness of Four Amniotic Membrane-based Skin Substitute Allografts Added to Standard Care in Chronic Diabetic Foot Ulcers, Venous Leg Ulcers, and Pressure Ulcers (HEAL-4): A Multi-Site Real-World Study
🩺 Plain-English Summary (8th-Grade Level)
This retrospective multi-site observational cohort study uses electronic health records (EHR) from U.S. wound care centers to evaluate the effectiveness of four amniotic membrane allografts (Acesso DL, Acesso TL, Neostim DL, Neostim TL) when added to standard wound care for diabetic foot ulcers (DFU), venous leg ulcers (VLU), and pressure ulcers (PU). The primary endpoint is complete wound closure by 12 weeks. Secondary outcomes include time-to-closure, ≥50% wound-area reduction at 4 weeks, wound-related complications (infection, hospitalization, emergency department visits, and major/minor amputation).
Who can join: Review the eligibility criteria below.
Location: Optalis — Novi, Michigan
Age range: 18 Years
📋 "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 (2 Sites)
- Optalis — Novi, Michigan
- ProCure Health — Murfreesboro, Tennessee
💰 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
- 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.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.