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

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).

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

Optalis, Novi, Michigan, 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 observability

Exclusion criteria

Non-study advanced biologic product use within 60 days pre-index; 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

Dynamic Medical Services dba Acesso Biologics

Industry

Registry information

Official study title

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

Acronym: HEAL-4

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Nov 3, 2025
Registry last updated: Nov 3, 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