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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective Relese | Retrospective case review to include all subjects that received Relese between May 2023 to April 2025. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Area Reduction for Treated Ulcers Over 12 Weeks | Percent Area Reduction (PAR) will be calculated from Treatment Visit 1 to Treatment Visit 12. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive subjects receiving Relese in a real-world setting
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cypress Wound Care | Oklahoma City | Oklahoma | 73103 | United States | ||
| Premier Foot & Ankle |
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| ID | Title | Description |
|---|---|---|
| FG000 | Retrospective Relese | Retrospective case review to include all subjects that received Relese between May 2023 to April 2025. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 23 patients with 26 ulcers (3 patients receiving treatment on 2 wounds each).
| ID | Title | Description |
|---|---|---|
| BG000 | Retrospective Relese | Retrospective case review to include all subjects that received Relese between May 2023 to April 2025. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Units | 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. | ulcers | ulcers |
|
Safety observations from enrollment through follow-up until ulcer closure or last visit out to 15 weeks
All complications and events were reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Retrospective Relese | Retrospective case review to include all subjects that received Relese between May 2023 to April 2025. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection leading to amputation and hospitalization | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa O'Connor | StimLabs | 888.346.9802 | melissa@stimlabs.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2025 | Feb 12, 2026 | Prot_SAP_000.pdf |
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| 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. |
| 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. |
| Denison |
| Texas |
| 75020 |
| United States |
| Premier Foot & Ankle | Frisco | Texas | 75033 | United States |
| ulcers |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Diabetes, Type 2 | Number | Participants | Participants |
|
|
| Ulcer duration prior to treatment | Median | Inter-Quartile Range | days | ulcers |
|
|
| Wound area at first application of the dehydrated complete human placental membrane (dCHPM) | Median | Inter-Quartile Range | cm^2 | ulcers |
|
|
| Units | Counts |
|---|
| Participants |
|
| ulcers |
|
|
| Secondary | Percent Area Reduction for Treated Ulcers Over 12 Weeks | Percent Area Reduction (PAR) will be calculated from Treatment Visit 1 to Treatment Visit 12. | Posted | Mean | Standard Deviation | Percent (%) | 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. | ulcers | ulcers |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | days | 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. | ulcers | ulcers |
|
|
|
| 0 |
| 23 |
| 2 |
| 23 |
| 5 |
| 23 |
| Inguinal hernia repair | Surgical and medical procedures | Non-systematic Assessment |
|
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