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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Kerecis Ltd. Industry-sponsored |
| Locations | 1 site (Monroeville, Pennsylvania) |
| Status | Recruiting |
| Started | January 2025 |
| Main results expected | October 2026 |
| Study ends | December 2026 |
| Registry record updated | January 24, 2025 |
| Trial ID | NCT06697925 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
- Study coordinator: Bennett Rogers
- Email: brogers@serenagroups.com
- Phone: 888-960-1343
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Human placental membrane products plus standard care for nonhealing diabetic foot and venous leg ulcers
This trial will try human placental membrane products together with standard wound care to help adults whose diabetic foot ulcers or venous leg ulcers have not healed.
-
GORE VIABAHN FORTEGRA Venous Stent Post-Approval Study
This study tests the GORE VIABAHN FORTEGRA Venous Stent in real-world patients with venous diseases to see how it performs after it is approved.
-
Evaluating new treatments for nonhealing diabetic foot and venous leg ulcers.
This study is testing whether new treatments for stubborn diabetic foot and leg ulcers can help people heal better when combined with standard care compared to just standard care alone.
-
New gel treatment for venous leg ulcers
This study is testing a new gel treatment for people with stubborn venous leg ulcers to see if it helps them heal better than just the usual care.
-
Tissue Repair Gel for treating Venous Leg Ulcers
This study is testing a new gel to see if it helps people with stubborn leg ulcers heal better when used with standard treatment compared to standard treatment alone.
-
Using fish skin grafts to treat nonhealing venous leg ulcers
This study is testing whether using fish skin grafts along with regular treatment can help people with stubborn leg ulcers heal better than just using regular treatment alone.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.