NCT07223281

Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU

Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in Chronic Wound Healing: A Multi-Site Study in Diabetic Foot Ulcers (DFU), Venous Leg Ulcers (VLU), and Pressure Ulcers (PU)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,400 (estimated)
• Sponsor: Legacy Medical Consultants · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This observational study will evaluate the real-world effectiveness of four amniotic membrane-based products (Zenith™, Orion™, SurGraft FT™, Complete ACA™) in addition to standard care, compared with standard care alone. The study will use complete electronic health records (EHR) from multiple wound care centers across the United States (2022-2025) to generate study data for product-treated and propensity score-matched standard care cohorts for each product-indication combination. The overall study comprises 12 parallel sub-studies (one for each product-wound type combination), each aiming to answer whether adding the product improves healing outcomes versus standard care alone in that indication. The primary endpoint is the proportion of wounds achieving complete closure within 12 weeks, with subgroup analyses by wound severity measures, age groups, and number of product applications. Secondary outcomes are time-to-healing, early wound improvement (≥50% reduction in wound area by 4 weeks), wound-related complications, and subgroup analyses.

Conditions

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

Timeline

• Start date: 2025-09-25
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2025-10-31
• Last updated: 2025-11-10

Locations

4 sites across 1 country: United States