NCT07223515

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Dynamic Medical Services dba Acesso Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diabetic Foot Ulcer (DFU)
• Venous Leg Ulcers (VLUs)
• Pressure Ulcers, Bedsores, Decubitus Ulcer

Timeline

• Start date: 2025-10-24
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2025-11-03
• Last updated: 2025-11-03

Locations

2 sites across 1 country: United States