Prospective Multicenter Observational Study Evaluating the Durability of Closure for Venous Leg Ulcers Following a Randomized, Controlled, Clinical Trial

Kerecis Ltd.1 site in 1 country150 target enrollmentJanuary 2025

ConditionsVenous Leg Venous Leg Ulcer (VLU)Venous Leg Ulcer Venous Ulcer VLU

Overview

Phase: N/A
Intervention: Not specified
Conditions: Venous Leg
Sponsor: Kerecis Ltd.
Enrollment: 150
Locations: 1
Primary Endpoint: Durability of closure
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

January 2025

End Date

December 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Kerecis Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.