Evaluating the Durability of Closure for Venous Leg Ulcers

Recruiting

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

• Registration Number: NCT06697925
• Lead Sponsor: Kerecis Ltd.

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 Timeline

• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-20
• Status Verified: 2024-12
• Study Start: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-24
• Primary Completion: 2026-10
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Durability of closure	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.

Trial Locations

Locations (1)

Serena Group; 🇺🇸 Monroeville, Pennsylvania, United States