NCT06697925Recruiting
Evaluating the Durability of Closure for Venous Leg Ulcers
Kerecis Ltd.
Start Date
1/1/2025
Completion Date
12/1/2026
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Conditions
Venous LegVenous Leg Ulcer (VLU)Venous Leg UlcerVenous UlcerVLU
Locations
Serena Group
Monroeville, Pennsylvania 15146
United States