Prospective Multicenter Observational Study Evaluating the Durability of Closure for Venous Leg Ulcers Following a Randomized, Controlled, Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Kerecis Ltd.
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Durability of closure
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects must have participated in the THOR trial and achieved complete closure by the 12-week endpoint.
Exclusion Criteria
- •Subjects who did not participate in the THOR trial.
- •Subjects who participated in the THOR trial and did not achieve complete closure.
Outcomes
Primary Outcomes
Durability of closure
Time Frame: 12-month follow-up
To demonstrate 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.
Secondary Outcomes
No secondary outcomes reported