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Durability of Closure for Venous Leg Ulcers After THOR Trial

This study is looking at how long venous leg ulcers (open sores on the legs due to poor blood flow) stay closed after treatment. Specifically, it's following people who participated in a previous study called THOR and whose ulcers completely healed. The THOR trial compared treatment with Intact Fish Skin Graft (IFSG) plus standard care to standard care alone. This new study wants to see if those healed ulcers remain closed for 12 months. You can join if you were in the THOR trial and your ulcer healed completely by 12 weeks. The study aims to enroll 150 participants.

Study design
This is an observational study, meaning researchers will watch and collect information without providing new treatments. It plans to include 150 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months to see if their ulcers remain closed.

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NCT06697925

Evaluating the Durability of Closure for Venous Leg Ulcers

Recruiting
Not specifiedAges 18+Observational
Kerecis Ltd.
~150 participants
Updated 2025-01-24 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Durability of closure
Measured over 12-month follow-up

Conditions

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

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Where it's being run

1 sites across 1 states
Pennsylvania1

Who to contact

Bennett Rogers
[email protected]
888-960-1343 · ext. 1008
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Eligibility criteria

Inclusion

1\. Subjects must have participated in the THOR trial and achieved complete closure by the 12-week endpoint.

Exclusion

1\. Subjects who did not participate in the THOR trial. 2. Subjects who participated in the THOR trial and did not achieve complete closure.

What this trial measures

  • Durability of closure12-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.