Clinical trial Recruiting at 1 site Observational Ages 18 and up

Evaluating how long venous leg ulcers stay closed after treatment

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

Run by Kerecis Ltd. · NCT06697925 · Data updated 2026-11-12

This study is testing how long venous leg ulcers stay closed after treatment with a special fish skin graft compared to standard care alone.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment150 (estimated)
SponsorKerecis Ltd.
Industry-sponsored
Locations1 site (Monroeville, Pennsylvania)
StatusRecruiting
StartedJanuary 2025
Main results expectedOctober 2026
Study endsDecember 2026
Registry record updatedJanuary 24, 2025
Trial IDNCT06697925 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals who participated in the THOR trial and achieved complete closure of their venous leg ulcers.

Probably not a fit

Patients who did not participate in the THOR trial or did not achieve complete closure will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the durability of closure for venous leg ulcers in patients who previously achieved closure during the THOR trial. It compares the recurrence rates of ulcers in subjects treated with Intact Fish Skin Graft (IFSG) plus standard of care against those treated with standard of care alone. By following up on these patients, the study seeks to provide insights into the long-term effectiveness of the treatments used in the THOR trial.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the long-term effectiveness of treatments for venous leg ulcers, potentially leading to improved management strategies.

How similar studies have gone: While this study builds on findings from the THOR trial, the specific focus on durability of closure has not been extensively tested in similar studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Serena Group
    Monroeville, Pennsylvania, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.