Clinical Trial

HEAL-4: Real-World Effectiveness of 4 Amniotic Allografts Adjunctive to Standard Care in DFU, VLU, and PU

Study acronym: HEAL-4
Active, Not Recruiting
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Summary
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).
Trial Details
NCT Number NCT07223515
Lead Sponsor Dynamic Medical Services dba Acesso Biologics
Conditions Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
Enrollment 2,000 participants
Start Date 2025-10-24
Primary Completion 2025-11 (estimated)
Study Completion 2025-11 (estimated)
Updated on ClinicalTrials.gov 2025-11-03