Ireland
--:--IST
Recruiting Observational

Evaluating the Durability of Closure for Venous Leg Ulcers

NCT06697925 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2025-01
Last updated
2025-01-24

Condition(s) studied

Venous LegVenous Leg Ulcer (VLU)Venous Leg UlcerVenous UlcerVLU

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
Serena Group Monroeville Pennsylvania Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06697925 on ClinicalTrials.gov ↗ ← All trials in the USA