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

Running, not enrolling

Conditions studied: Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer

In brief

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.

Key facts

Study ID

NCT07223281

Run by

Legacy Medical Consultants

People needed

2400

Starts

2025-09-25

Expected to finish

2025-12-01

Last updated by the study team

2025-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults ≥18; DFU/VLU/PU; sufficient observable timeline

You may not qualify if…

• Use of other advanced wound products, atypical ulcer etiology (e.g., malignancy, vasculitis); insufficient follow-up

Where it is running

• Colorado Foot and Ankle — Colorado Springs, Colorado, United States
• Podiatric Surgical Specialists — Clinton Township, Michigan, United States
• Advanced Wound Therapy — Tulsa, Oklahoma, United States
• Comprehensive Occupational Medicine — Nitro, West Virginia, United States

Full record on ClinicalTrials.gov

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