An observational study in Chronic Wounds and Diabetic Ulcers, sponsored by StimLabs. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by StimLabs · Observational
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). The collection of retrospective real-world data provides a broad range of experiences related to patient healthcare and treatment.
359 studies on the registry are indexed under Ulcer; 62 are open to participants now.
This study's enrollment of 23 is below the median of 100 across 55 observational studies indexed under Ulcer.
Browse Ulcer studies →StimLabs is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
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Consecutive subjects receiving Relese in a real-world setting
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Retrospective case review to include all subjects that received Relese between May 2023 to April 2025.
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.
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.
Percent Area Reduction for Treated Ulcers Over 12 Weeks
Percent Area Reduction (PAR) will be calculated from Treatment Visit 1 to Treatment Visit 12.
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 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.
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.
| Milestone | Retrospective Relese |
|---|---|
| Started | 23 |
| Completed | 23 |
| Not completed | 0 |
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.
| ulcers | Retrospective Relese |
|---|---|
| The Percentage of Treated Target Ulcers Achieving Complete Wound Closure During the Observational Period | 13 |
Percent Area Reduction (PAR) will be calculated from Treatment Visit 1 to Treatment Visit 12.
| Percent (%) | Retrospective Relese |
|---|---|
| Percent Area Reduction for Treated Ulcers Over 12 Weeks | 56.4 ± 97.8 |
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.
| days | Retrospective Relese |
|---|---|
| Time to Closure for the Treated Target Ulcers | 49.0 (21.0 to 63.0) |
Collected over Safety observations from enrollment through follow-up until ulcer closure or last visit out to 15 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Retrospective Relese | 0/23 (0%) | 2/23 (8.7%) | 5/23 (21.7%) |
| Event | Retrospective Relese |
|---|---|
| Infection leading to amputation and hospitalizationInfections and infestations | 1/23 |
| Inguinal hernia repairSurgical and medical procedures | 1/23 |
| Event | Retrospective Relese |
|---|---|
| InfectionInfections and infestations | 5/23 |
A total of 23 patients with 26 ulcers (3 patients receiving treatment on 2 wounds each).
| Age, Continuous(years) | Retrospective Relese |
|---|---|
| Mean | 76.0 (72.0 to 84.0) |
| Sex: Female, Male(Participants) | Retrospective Relese |
|---|---|
| Female | 8 |
| Male | 15 |
| Race and Ethnicity Not Collected(Participants) | Retrospective Relese |
|---|
| Diabetes, Type 2(Participants) | Retrospective Relese |
|---|---|
| Number | 12 |
| Ulcer duration prior to treatment(days) | Retrospective Relese |
|---|---|
| Median | 42.0 (28.0 to 91.0) |
| Wound area at first application of the dehydrated complete human placental membrane (dCHPM)(cm^2) | Retrospective Relese |
|---|---|
| Median | 1.27 (0.64 to 2.34) |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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