Evaluating the Durability of Closure for Venous Leg Ulcers
THORSDOTTIR
Prospective Multicenter Observational Study Evaluating the Durability of Closure for Venous Leg Ulcers Following a Randomized, Controlled, Clinical Trial
1 other identifier
observational
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2024
CompletedFirst Posted
Study publicly available on registry
November 20, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 24, 2025
December 1, 2024
1.7 years
November 18, 2024
January 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Durability of closure
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.
12-month follow-up
Study Arms (1)
Thor closure patients
Patients who achieved closure in during the THOR clinical trial
Eligibility Criteria
Patients who achieved closure in during the THOR clinical trial
You may qualify if:
- \. Subjects must have participated in the THOR trial and achieved complete closure by the 12-week endpoint.
You may not qualify if:
- \. Subjects who did not participate in the THOR trial. 2. Subjects who participated in the THOR trial and did not achieve complete closure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kerecis Ltd.lead
- Serena Groupcollaborator
Study Sites (1)
Serena Group
Monroeville, Pennsylvania, 15146, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2024
First Posted
November 20, 2024
Study Start
January 1, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 24, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share