Recruiting

Venous Leg Ulcers

Sponsor:

Kerecis Ltd.

Code:

NCT06697925

Conditions

Venous Leg

Venous Leg Ulcer (VLU)

Venous Leg Ulcer

Venous Ulcer

VLU

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Venous Leg

Venous Leg Ulcer (VLU)

Venous Leg Ulcer

Venous Ulcer

VLU

Study ID

NCT06697925

Start date

Jan, 2025

Status verified date

Dec, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Thor closure patients

Patients who achieved closure in during the THOR clinical trial

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Bennett Rogers

888-960-1343brogers@serenagroups.com

Thomas Serena, MD

814-688-4000tserena@serenagroups.com

Locations

Serena Group

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Laura Serena

412-212-0123lserena@serenagorups.com

More Information

Sponsor

Kerecis Ltd.

Last update posted

Jan 24, 2025

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kerecis Ltd. on 2025-01-24.