Evaluating the Durability of Closure for Venous Leg Ulcers
Purpose
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.
Conditions
- Venous Leg
- Venous Leg Ulcer (VLU)
- Venous Leg Ulcer
- Venous Ulcer
- VLU
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Thor closure patients | Patients who achieved closure in during the THOR clinical trial |
Recruiting Locations
Serena Group
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
More Details
- Status
- Recruiting
- Sponsor
- Kerecis Ltd.
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.