Study detail
Recruiting
Prospective Multicenter Observational Study Evaluating the Durability of Closure for Venous Leg Ulcers Following a Randomized, Controlled, Clinical Trial
Kerecis Ltd.
Summary
The goal of this observational study is to determine the durability of closure for venous leg ulcer subjects that achieved closure in the THOR trial.
Description
To determine durability of closure (rate of target wound recurrence) of subjects with a closed venous leg ulcer during the THOR clinical trial comparing subjects treated with Intact Fish Skin Graft (IFSG) plus standard of care (SOC) to subjects treated with SOC alone.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Detailed criteria
Inclusion Criteria: * 1\. Subjects must have participated in the THOR trial and achieved complete closure by the 12-week endpoint. Exclusion Criteria: * 1\. Subjects who did not participate in the THOR trial. 2. Subjects who participated in the THOR trial and did not achieve complete closure.
Location
- Serena GroupMonroeville, Pennsylvania