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

NCT07223515 | Active Not Recruiting

• 1 other identifier: AB-RWE-2025-01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 2

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Complete wound closure at 12 Weeks

  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 Outcomes (3)

• Time to complete wound closure

  From index visit up to 24 months post-index

• ≥50% wound area reduction at 4 weeks

  From index visit to 4 weeks post-index

• Wound-related complications

  From index visit up to 24 months post-index

Study Arms (15)

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

Standard care alone for DFU

Patients who received standard care only 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

Standard care alone for VLU

Patients who received standard care only 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

Standard care alone for PU

Patients who received standard care only for their PU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with DFU, VLU, or PU

You may qualify if:

• Adults ≥18; DFU/VLU/PU; sufficient observability

You may not qualify if:

• Non-study advanced biologic product use within 60 days pre-index; insufficient follow-up

Sponsors & Collaborators

• Dynamic Medical Services dba Acesso Biologics: lead

Study Sites (2)

Optalis

Novi, Michigan, 48375, United States

Location

ProCure Health

Murfreesboro, Tennessee, 37129, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Pressure Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: November 3, 2025
• Study Start: October 24, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 3, 2025

Record last verified: 2025-10

Locations

US (2)