Evaluating the Durability of Closure for Venous Leg Ulcers

Kerecis Ltd.150 enrolled

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.

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 Type

OBSERVATIONAL

Enrollment

150

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Serena Group

Monroeville, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Durability of closure

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.

Time frame: 12-month follow-up

Central Contacts

Bennett Rogers

CONTACT

888-960-1343 brogers@serenagroups.com

Thomas Serena, MD

CONTACT

814-688-4000 tserena@serenagroups.com

Data from ClinicalTrials.gov

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