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

November 5, 2025 updated by: Legacy Medical Consultants

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80903
        • Colorado Foot and Ankle
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Podiatric Surgical Specialists
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74137
        • Advanced Wound Therapy
    • West Virginia
      • Nitro, West Virginia, United States, 25143
        • Comprehensive Occupational Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with DFU, VLU, or PU

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Zenith™ + Standard care for DFU
Patients who received Zenith™ plus standard care for their DFU
Orion™ + Standard care for DFU
Patients who received Orion™ plus standard care for their DFU
SurGraft FT™ + Standard care for DFU
Patients who received SurGraft FT™ plus standard care for their DFU
Complete ACA™ + Standard care for DFU
Patients who received Complete ACA™ plus standard care for their DFU
Standard care alone for DFU
Patients who received standard care only for their DFU
Zenith™ + Standard care for VLU
Patients who received Zenith™ plus standard care for their VLU
Orion™ + Standard care for VLU
Patients who received Orion™ plus standard care for their VLU
SurGraft FT™ + Standard care for VLU
Patients who received SurGraft FT™ plus standard care for their VLU
Complete ACA™ + Standard care for VLU
Patients who received Complete ACA™ plus standard care for their VLU
Standard care alone for VLU
Patients who received standard care only for their VLU
Zenith™ + Standard care for PU
Patients who received Zenith™ plus standard care for their PU
Orion™ + Standard care for PU
Patients who received Orion™ plus standard care for their PU
SurGraft FT™ + Standard care for PU
Patients who received SurGraft FT™ plus standard care for their PU
Complete ACA™ + Standard care for PU
Patients who received Complete ACA™ plus standard care for their PU
Standard care alone for PU
Patients who received standard care only for their PU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From index visit to 12 weeks post-index

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From index visit up to 24 months post-index
≥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
From index visit to 4 weeks post-index
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
From index visit up to 24 months post-index

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Legacy Medical Consultants

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Kahoun, J., Gorenstein, S., & Gillette, B. (2025). Real-World Performance of Amniotic Membrane Allografts for Chronic Wounds: Multi-Site Results from a Retrospective EHR Study. https://doi.org/10.5281/zenodo.17504472

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2025

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 29, 2025

First Submitted That Met QC Criteria

October 29, 2025

First Posted (Estimated)

October 31, 2025

Study Record Updates

Last Update Posted (Actual)

November 10, 2025

Last Update Submitted That Met QC Criteria

November 5, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMCRWE25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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