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

October 29, 2025 updated by: Dynamic Medical Services dba Acesso Biologics

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

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
    • Michigan
      • Novi, Michigan, United States, 48375
        • Optalis
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37129
        • ProCure Health

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 observability

Exclusion Criteria:

  • Non-study advanced biologic product use within 60 days pre-index; 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
Standard care alone for DFU
Patients who received standard care only for their DFU
Standard care alone for VLU
Patients who received standard care only for their VLU
Standard care alone for PU
Patients who received standard care only for their PU
Acesso DL + Standard care for DFU
Patients who received Acesso DL plus standard care for their DFU
Acesso TL + Standard care for DFU
Patients who received Acesso TL plus standard care for their DFU
Neostim DL + Standard care for DFU
Patients who received Neostim DL plus standard care for their DFU
Neostim TL + Standard care for DFU
Patients who received Neostim TL plus standard care for their DFU
Acesso DL + Standard care for VLU
Patients who received Acesso DL plus standard care for their VLU
Acesso TL + Standard care for VLU
Patients who received Acesso TL plus standard care for their VLU
Neostim DL + Standard care for VLU
Patients who received Neostim DL plus standard care for their VLU
Neostim TL + Standard care for VLU
Patients who received Neostim TL plus standard care for their VLU
Acesso DL + Standard care for PU
Patients who received Acesso DL plus standard care for their PU
Acesso TL + Standard care for PU
Patients who received Acesso TL plus standard care for their PU
Neostim DL + Standard care for PU
Patients who received Neostim DL plus standard care for their PU
Neostim TL + Standard care for PU
Patients who received Neostim TL plus standard care 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

Dynamic Medical Services dba Acesso Biologics

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)

October 24, 2025

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

September 19, 2025

First Submitted That Met QC Criteria

October 29, 2025

First Posted (Estimated)

November 3, 2025

Study Record Updates

Last Update Posted (Estimated)

November 3, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB-RWE-2025-01

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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