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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetic Foot Ulcer (DFU) Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Pressure Ulcer Pressure Ulcers, Bedsores, Decubitus Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases Venous Leg Ulcers (VLUs)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Colorado Foot and Ankle, Colorado Springs, Colorado, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Complete wound closure at 12 Weeks

Time frame: From index visit to 12 weeks post-index

Proportion of index wounds with 100% epithelialization, no drainage or dressings; confirmation on ≥1 follow-up within 60 days

Secondary outcomes

Time to complete wound closure

Time frame: From index visit up to 24 months post-index

Time from the index visit to primary complete wound closure for wounds that heal during the study period
≥50% wound area reduction at 4 weeks

Time frame: From index visit to 4 weeks post-index

Proportion of patients whose wounds close greater than 50% within 4 weeks from the index visit
Wound-related complications

Time frame: From index visit up to 24 months post-index

Wound-related complications including infection requiring treatment, hospitalization, ED visits, and major or minor amputation

Sponsors and collaborators

Lead sponsor

Legacy Medical Consultants

Industry

Registry information

Official study title

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)

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Oct 31, 2025
Registry last updated: Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting