Diabetic Foot Ulcer (DFU)HEAL-4NCT07223515
HEAL-4: Real-World Effectiveness of 4 Amniotic Allografts Adjunctive to Standard Care in DFU, VLU, and PU
An observational study of Diabetic Foot Ulcer (DFU) and Venous Leg Ulcers (VLUs), run by Dynamic Medical Services dba Acesso Biologics at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- How many people
- 2,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Oct 2025to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with DFU, VLU, or PU
Who may be able to join
- Adults ≥18; DFU/VLU/PU; sufficient observability
Who cannot join
- Non-study advanced biologic product use within 60 days pre-index; insufficient follow-up
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ProCure Health
Murfreesboro, Tennessee, 37129
Optalis
Novi, Michigan, 48375
About this study
Official title: 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
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
- Medical subject headings
- Diabetic Foot, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From index visit to 12 weeks post-index
Secondary outcomes (3)
Time to complete wound closure
Time from the index visit to primary complete wound closure for wounds that heal during the study period
Measured: From index visit up to 24 months post-index
≥50% wound area reduction at 4 weeks
Proportion of patients whose wounds close greater than 50% within 4 weeks from the index visit
Measured: From index visit to 4 weeks post-index
Wound-related complications
Wound-related complications including infection requiring treatment, hospitalization, ED visits, and major or minor amputation
Measured: From index visit up to 24 months post-index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start24 Oct 2025
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dynamic Medical Services dba Acesso Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223515
- Sponsor's protocol ID
- AB-RWE-2025-01
- Acronym
- HEAL-4
- Status last verified
- Oct 2025
- First submitted
- 19 Sep 2025
- Last updated
- 3 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07223515
- Acronym / sponsor ID
- HEAL-4 / AB-RWE-2025-01
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Dynamic Medical Services dba Acesso BiologicsIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 3 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with DFU, VLU, or PU
Key inclusion criteria (1 listed)
- Adults ≥18; DFU/VLU/PU; sufficient observability
Key exclusion criteria (1 listed)
- Non-study advanced biologic product use within 60 days pre-index; insufficient follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete wound closure at 12 Weeks
Time frame: 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
3 secondary outcomes
Time to complete wound closure
Time frame: From index visit up to 24 months post-index
≥50% wound area reduction at 4 weeks
Time frame: From index visit to 4 weeks post-index
Wound-related complications
Time frame: From index visit up to 24 months post-index
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer (DFU) and Venous Leg Ulcers (VLUs), run by Dynamic Medical Services dba Acesso Biologics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete wound closure at 12 Weeks (time frame: From index visit to 12 weeks post-index). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.