Chronic Wounds, Diabetic Ulcers
Conditions
Brief 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). The collection of retrospective real-world data provides a broad range of experiences related to patient healthcare and treatment.
Interventions
None listed
Sponsors
StimLabs
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive diabetic subjects that received a Relese product application during treatment between May 2023 and April 2025.
Exclusion criteria
* Subjects not receiving an initial Relese application during treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Treated Target Ulcers Achieving Complete Wound Closure During the Observational Period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Area Reduction for Treated Ulcers Over 12 Weeks | 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 (PAR) will be calculated from Treatment Visit 1 to Treatment Visit 12. |
| Time to Closure for the Treated Target Ulcers | 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 (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. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 76.0 years |
| Diabetes, Type 2 | 12 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 15 Participants |
| Ulcer duration prior to treatment | 42.0 days |
| Wound area at first application of the dehydrated complete human placental membrane (dCHPM) | 1.27 cm^2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 5 / 23 |
| serious Total, serious adverse events | 2 / 23 |
Outcome results
None listed