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

Dynamic Medical Services dba Acesso Biologics

Status: Active, not recruiting

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

Study type: Observational

Funder types: Industry

Identifiers

NCT07223515

AB-RWE-2025-01

Details and patient eligibility

About

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).

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

2,000 participants in 15 patient groups

Acesso DL + Standard care for DFU

Description:

Patients who received Acesso DL plus standard care for their DFU

Acesso TL + Standard care for DFU

Description:

Patients who received Acesso TL plus standard care for their DFU

Neostim DL + Standard care for DFU

Description:

Patients who received Neostim DL plus standard care for their DFU

Neostim TL + Standard care for DFU

Description:

Patients who received Neostim TL plus standard care for their DFU

Standard care alone for DFU

Description:

Patients who received standard care only for their DFU

Acesso DL + Standard care for VLU

Description:

Patients who received Acesso DL plus standard care for their VLU

Acesso TL + Standard care for VLU

Description:

Patients who received Acesso TL plus standard care for their VLU

Neostim DL + Standard care for VLU

Description:

Patients who received Neostim DL plus standard care for their VLU

Neostim TL + Standard care for VLU

Description:

Patients who received Neostim TL plus standard care for their VLU

Standard care alone for VLU

Description:

Patients who received standard care only for their VLU

Acesso DL + Standard care for PU

Description:

Patients who received Acesso DL plus standard care for their PU

Acesso TL + Standard care for PU

Description:

Patients who received Acesso TL plus standard care for their PU

Neostim DL + Standard care for PU

Description:

Patients who received Neostim DL plus standard care for their PU

Neostim TL + Standard care for PU

Description:

Patients who received Neostim TL plus standard care for their PU

Standard care alone for PU

Description:

Patients who received standard care only for their PU