Trial Outcomes & Findings for Real-world Study of StimLabs Human Placental Membrane Tissue to Treat Hard-to-Heal Wounds (NCT NCT07215741)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

23 participants

Primary outcome timeframe

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 posted on

2026-06-30

Participant Flow

Participant milestones

Participant milestones
Measure	Retrospective Relese Retrospective case review to include all subjects that received Relese between May 2023 to April 2025.
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Retrospective Relese n=26 ulcers Retrospective case review to include all subjects that received Relese between May 2023 to April 2025.
Age, Continuous	76.0 years n=23 Participants
Sex: Female, Male Female	8 Participants n=23 Participants
Sex: Female, Male Male	15 Participants n=23 Participants
Diabetes, Type 2	12 Participants n=23 Participants
Ulcer duration prior to treatment	42.0 days n=26 ulcers
Wound area at first application of the dehydrated complete human placental membrane (dCHPM)	1.27 cm^2 n=26 ulcers

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Retrospective Relese n=26 ulcers 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	13 ulcers

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Retrospective Relese n=26 ulcers Retrospective case review to include all subjects that received Relese between May 2023 to April 2025.
Percent Area Reduction for Treated Ulcers Over 12 Weeks	56.4 Percent (%) Standard Deviation 97.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Retrospective Relese n=26 ulcers Retrospective case review to include all subjects that received Relese between May 2023 to April 2025.
Time to Closure for the Treated Target Ulcers	49.0 days Interval 21.0 to 63.0

Adverse Events

Retrospective Relese

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Retrospective Relese n=23 participants at risk Retrospective case review to include all subjects that received Relese between May 2023 to April 2025.
Infections and infestations Infection leading to amputation and hospitalization	4.3% 1/23 • Safety observations from enrollment through follow-up until ulcer closure or last visit out to 15 weeks All complications and events were reported
Surgical and medical procedures Inguinal hernia repair	4.3% 1/23 • Safety observations from enrollment through follow-up until ulcer closure or last visit out to 15 weeks All complications and events were reported

Other adverse events

Other adverse events
Measure	Retrospective Relese n=23 participants at risk Retrospective case review to include all subjects that received Relese between May 2023 to April 2025.
Infections and infestations Infection	21.7% 5/23 • Safety observations from enrollment through follow-up until ulcer closure or last visit out to 15 weeks All complications and events were reported

Additional Information

Melissa O'Connor

StimLabs

Phone: 888.346.9802

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60