Chronic WoundsNCT07215741

Real-world Study of StimLabs Human Placental Membrane Tissue to Treat Hard-to-Heal Wounds

An observational study of Chronic Wounds and Diabetic Ulcers, run by StimLabs at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a retrospective, multi-center observational study to assess real-world outcomes of StimLabs human placental membrane tissue used in the treatment of hard-to-heal wounds, including chronic ulcers, diabetic foot ulcers (DFUs), and venous leg ulcers (VLUs). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Wounds, Diabetic Ulcers
How many people: 23 participants
Where: 3 sitesUnited States
Study dates: 1 Sep 2025to 1 Nov 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Consecutive subjects receiving Relese in a real-world setting

Who may be able to join

Consecutive diabetic subjects that received a Relese product application during treatment between May 2023 and April 2025.

Who cannot join

Subjects not receiving an initial Relese application during treatment.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Premier Foot & Ankle
Denison, Texas, 75020
Premier Foot & Ankle
Frisco, Texas, 75033
Cypress Wound Care
Oklahoma City, Oklahoma, 73103

Other trials in United States

About this study

Official title: A Retrospective, Multi-center Real-world Study of StimLabs Human Placental Membrane Tissue Used for Treatment in Hard-to-Heal Wounds

Conditions: Chronic Wounds, Diabetic Ulcers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07215741
Study group	Role	What they receive
Retrospective Relese		Retrospective case review to include all subjects that received Relese between May 2023 to April 2025.

What is being measured

The primary outcome is the main question the study is designed to answer.

The Percentage of Treated Target Ulcers Achieving Complete Wound Closure During the Observational Period
Determine the percent (%) of target ulcers achieving complete wound closure at 12 weeks through the observational period.
Target ulcers were defined as all eligible ulcers treated during the observational period. Multiple target ulcers from a single participant were permitted and analyzed individually.
Measured: Data were collected retrospectively from health registries, for up to 12 weeks after the procedure, hence timeframe may exceed the study duration in this outcome measure.

Secondary outcomes (2)

Percent Area Reduction for Treated Ulcers Over 12 Weeks
Percent Area Reduction (PAR) will be calculated from Treatment Visit 1 to Treatment Visit 12.
Measured: Data were collected retrospectively from health registries, for up to 12 weeks after the procedure, hence timeframe may exceed the study duration in this outcome measure.
Time to Closure for the Treated Target Ulcers
Time to closure (days) will be determined from the first product application to the date when the wound is first documented as fully closed.
Target ulcers were defined as all eligible ulcers treated during the observational period. Multiple target ulcers from a single participant were permitted and analyzed individually.
Measured: Data were collected retrospectively from health registries, for up to 12 weeks after the procedure, hence timeframe may exceed the study duration in this outcome measure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20251 Nov 2025

First posted10 Oct 2025
Study start1 Sep 2025
Primary completion1 Nov 2025
Study completion1 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic WoundsStudies 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: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07215741
Sponsor's protocol ID: REL2501.000-M (07/25)
Status last verified: Sep 2025
First submitted: 25 Sep 2025
Last updated: 30 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
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Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
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Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma

All Chronic Wounds trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Retrospective, Multi-center Real-world Study of StimLabs Human Placental Membrane Tissue Used for Treatment in Hard-to-Heal Wounds
ClinicalTrials.gov ID: NCT07215741
Acronym / sponsor ID: REL2501.000-M (07/25)
Conditions: Chronic Wounds, Diabetic Ulcers
Study type: Observational
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: StimLabsIndustry (pharma, biotech, devices)
Study start: 1 Sep 2025 (actual)
Primary completion: 1 Nov 2025 (actual)
Study completion: 1 Nov 2025 (actual)
First posted: 10 Oct 2025 (actual)
Results: Posted 30 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Retrospective Relese	–	–Retrospective case review to include all subjects that received Relese between May 2023 to April 2025.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Consecutive subjects receiving Relese in a real-world setting

Key inclusion criteria (1 listed)

Consecutive diabetic subjects that received a Relese product application during treatment between May 2023 and April 2025.

Key exclusion criteria (1 listed)

Subjects not receiving an initial Relese application during treatment.

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

The Percentage of Treated Target Ulcers Achieving Complete Wound Closure During the Observational Period
Time frame: Data were collected retrospectively from health registries, for up to 12 weeks after the procedure, hence timeframe may exceed the study duration in this outcome measure.
Determine the percent (%) of target ulcers achieving complete wound closure at 12 weeks through the observational period. Target ulcers were defined as all eligible ulcers treated during the observational period. Multiple target ulcers from a single participant were permitted and analyzed individually.

2 secondary outcomes

Percent Area Reduction for Treated Ulcers Over 12 Weeks
Time frame: Data were collected retrospectively from health registries, for up to 12 weeks after the procedure, hence timeframe may exceed the study duration in this outcome measure.
Time to Closure for the Treated Target Ulcers
Time frame: Data were collected retrospectively from health registries, for up to 12 weeks after the procedure, hence timeframe may exceed the study duration in this outcome measure.

Results and safety

Results posted to the registry on 30 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Retrospective Relese	23	23

Primary outcome: The Percentage of Treated Target Ulcers Achieving Complete Wound Closure During the Observational Period

Time frame: Data were collected retrospectively from health registries, for up to 12 weeks after the procedure, hence timeframe may exceed the study duration in this outcome measure.. Count of units. Unit: ulcers

Measure	Retrospective Relese n = 23
Value	13

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety observations from enrollment through follow-up until ulcer closure or last visit out to 15 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Retrospective Relese	2 of 23 (8.7%)	5 of 23 (21.7%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Wounds

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma

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.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Wounds and Diabetic Ulcers, run by StimLabs at 3 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: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Percentage of Treated Target Ulcers Achieving Complete Wound Closure During the Observational Period (time frame: Data were collected retrospectively from health registries, for up to 12 weeks after the procedure, hence timeframe may exceed the study duration in this outcome measure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07215741.

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 30 Jun 2026.