Evaluating how long venous leg ulcers stay closed after treatment
Prospective Multicenter Observational Study Evaluating the Durability of Closure for Venous Leg Ulcers Following a Randomized, Controlled, Clinical Trial
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 type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kerecis Ltd. Industry-sponsored |
| Locations | 1 site (Monroeville, Pennsylvania) |
| Trial ID | NCT06697925 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals who participated in the THOR trial and achieved complete closure of their venous leg ulcers.
Not a fit: Patients who did not participate in the THOR trial or did not achieve complete closure will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Monroeville, Pennsylvania
- Serena Group — Monroeville, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Bennett Rogers
- Email: brogers@serenagroups.com
- Phone: 888-960-1343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.