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Recruiting NCT06697925

Evaluating the Durability of Closure for Venous Leg Ulcers

— Observational Venous Leg Venous Leg Ulcer (VLU) Venous Leg Ulcer Venous Ulcer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Venous Leg, Venous Leg Ulcer (VLU), Venous Leg Ulcer, Venous Ulcer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Durability of closure [Time frame: 12-month follow-up]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Serena Group — Monroeville

Identifiers

NCT: NCT06697925 · KS-1020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗