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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07223515

Acronym

HEAL-4

Enrollment

2000

Registered

2025-11-03

Start date

2025-10-24

Completion date

2025-11-30

Last updated

2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Complete wound closure at 12 Weeks	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

Measure	Time frame	Description
≥50% wound area reduction at 4 weeks	From index visit to 4 weeks post-index	Proportion of patients whose wounds close greater than 50% within 4 weeks from the index visit
Time to complete wound closure	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
Wound-related complications	From index visit up to 24 months post-index	Wound-related complications including infection requiring treatment, hospitalization, ED visits, and major or minor amputation

Countries

United States

Outcome results