NCT06697925

Evaluating the Durability of Closure for Venous Leg Ulcers

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Kerecis Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Leg
• Venous Leg Ulcer (VLU)
• Venous Leg Ulcer
• Venous Ulcer
• VLU

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2024-11-20
• Last updated: 2025-01-24

Locations

1 site across 1 country: United States