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NCT Number: NCT06697925

Evaluating the Durability of Closure for Venous Leg Ulcers

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.

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Key information

Conditions

Venous Leg Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases VLU Varicose Ulcer Varicose Veins Vascular Diseases Venous Leg Ulcer Venous Leg Ulcer (VLU) Venous Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Serena Group

Monroeville, Pennsylvania, 15146, United States

Location status: Recruiting

Location contact

Laura Serena

CONTACT

[email protected]

412-212-0123

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Durability of closure

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bennett Rogers

CONTACT

[email protected]

888-960-1343 ext. 1008

Thomas Serena, MD

CONTACT

[email protected]

814-688-4000

Sponsors and collaborators

Lead sponsor

Kerecis Ltd.

Industry

Collaborators

  • Serena Group

Registry information

Official study title

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

Acronym: THORSDOTTIR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2024
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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