Evaluating the Durability of Closure for Venous Leg Ulcers (THORSDOTTIR)

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Bennett Rogers; Phone Number: 1008 888-960-1343; Email: brogers@serenagroups.com
• Study Contact Backup: Name: Thomas Serena, MD; Phone Number: 814-688-4000; Email: tserena@serenagroups.com

Study Locations

• United States
  • Pennsylvania
    • Monroeville, Pennsylvania, United States, 15146
      • Recruiting
      • Serena Group
      • Contact: Laura Serena; Phone Number: 412-212-0123; Email: lserena@serenagorups.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who achieved closure in during the THOR clinical trial

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Thor closure patients; Patients who achieved closure in during the THOR clinical trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12-month follow-up

Collaborators and Investigators

• Sponsor: Kerecis Ltd.
• Collaborators: Serena Group

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Varicose Ulcer; Leg Ulcer
• Other Study ID Numbers: KS-1020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No