Evaluating the Durability of Closure for Venous Leg Ulcers (THORSDOTTIR)

Kerecis

Status: Enrolling

Conditions: Venous Leg Ulcer; Venous Ulcer; Venous Leg Ulcer (VLU); Venous Leg; VLU

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06697925

KS-1020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

Thor closure patients

Description:

Patients who achieved closure in during the THOR clinical trial