Evaluating the Durability of Closure for Venous Leg Ulcers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKerecis Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Subjects must have participated in the THOR trial and achieved complete closure by the 12-week endpoint.
Disqualifiers
1. Subjects who did not participate in the THOR trial. 2. Subjects who participated in the THOR trial and did not achieve complete closure.
Trial population
Patients who achieved closure in during the THOR clinical trial
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Thor closure patients
Trial outcomes
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.
Time frame
12-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kerecis Ltd.
Lead sponsor
Serena Group
Collaborator
Source ClinicalTrials.gov