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NCT07223515 · ClinicalTrials.gov registry record

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

A clinical trial of Diabetic Foot Ulcer (DFU) and Venous Leg Ulcers (VLUs), sponsored by Dynamic Medical Services dba Acesso Biologics.

Active
Registry status
2,000
Enrollment target
2
Study locations

NCT07223515 is a study of Diabetic Foot Ulcer (DFU) and Venous Leg Ulcers (VLUs) that is active but no longer recruiting, run by Dynamic Medical Services dba Acesso Biologics. The registered enrollment target is 2,000 participants, above the 364-participant average among 13 other Diabetic Foot Ulcer (DFU) trials with a reported enrollment target (449% higher). The trial reports 2 study locations across 2 states.

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The verdict

NCT07223515, a study of Diabetic Foot Ulcer (DFU) and Venous Leg Ulcers (VLUs), is active but no longer recruiting, sponsored by Dynamic Medical Services dba Acesso Biologics.

ACTIVE NOT RECRUITING
Registry status
2,000 participants
Enrollment target
2
Study locations

Study 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).

Study Locations (2)

Michigan

  • Optalis - Novi

Tennessee

  • ProCure Health - Murfreesboro

Trial Details

FieldValue
Enrollment Target 2,000 participants
Start Date 2025-10-24
Est. Completion 2025-11

What the Registry Record Tells You About NCT07223515

The ClinicalTrials.gov registry entry for NCT07223515 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 364-participant average among 13 other Diabetic Foot Ulcer (DFU) trials with a reported enrollment target (449% higher). The listed sponsor is Dynamic Medical Services dba Acesso Biologics, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Diabetic Foot Ulcer (DFU) appearing as the primary indexed condition, and to 0 interventions.

NCT07223515 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Michigan, Tennessee.

Frequently Asked Questions

What is clinical trial NCT07223515 about?

NCT07223515 is a clinical study titled "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...

What is the current status of trial NCT07223515?

This trial is currently active not recruiting. The enrollment target is 2,000 participants. The study started on 2025-10-24. Estimated completion is 2025-11.

What conditions does trial NCT07223515 study?

This clinical trial studies the following conditions: Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer.

Who is sponsoring clinical trial NCT07223515?

This trial is sponsored by Dynamic Medical Services dba Acesso Biologics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07223515 being conducted?

This trial has 2 study locations across Michigan, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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