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

NCT ID: NCT07223515

Last Updated: 2025-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-24

Study Completion Date

2025-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Acesso DL + Standard care for DFU

Patients who received Acesso DL plus standard care for their DFU

No interventions assigned to this group

Acesso TL + Standard care for DFU

Patients who received Acesso TL plus standard care for their DFU

No interventions assigned to this group

Neostim DL + Standard care for DFU

Patients who received Neostim DL plus standard care for their DFU

No interventions assigned to this group

Neostim TL + Standard care for DFU

Patients who received Neostim TL plus standard care for their DFU

No interventions assigned to this group

Standard care alone for DFU

Patients who received standard care only for their DFU

No interventions assigned to this group

Acesso DL + Standard care for VLU

Patients who received Acesso DL plus standard care for their VLU

No interventions assigned to this group

Acesso TL + Standard care for VLU

Patients who received Acesso TL plus standard care for their VLU

No interventions assigned to this group

Neostim DL + Standard care for VLU

Patients who received Neostim DL plus standard care for their VLU

No interventions assigned to this group

Neostim TL + Standard care for VLU

Patients who received Neostim TL plus standard care for their VLU

No interventions assigned to this group

Standard care alone for VLU

Patients who received standard care only for their VLU

No interventions assigned to this group

Acesso DL + Standard care for PU

Patients who received Acesso DL plus standard care for their PU

No interventions assigned to this group

Acesso TL + Standard care for PU

Patients who received Acesso TL plus standard care for their PU

No interventions assigned to this group

Neostim DL + Standard care for PU

Patients who received Neostim DL plus standard care for their PU

No interventions assigned to this group

Neostim TL + Standard care for PU

Patients who received Neostim TL plus standard care for their PU

No interventions assigned to this group

Standard care alone for PU

Patients who received standard care only for their PU

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dynamic Medical Services dba Acesso Biologics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Optalis

Novi, Michigan, United States

Site Status

ProCure Health

Murfreesboro, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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AB-RWE-2025-01

Identifier Type: -

Identifier Source: org_study_id

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