Actively Recruiting
Prospective Multicenter Observational Study Evaluating the Durability of Closure for Venous Leg Ulcers Following a Randomized, Controlled Trial
Led by Kerecis Ltd. · Updated on 2025-01-24
150
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
K
Kerecis Ltd.
Lead Sponsor
S
Serena Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate how long venous leg ulcers remain closed after treatment. It focuses on participants who previously took part in the THOR clinical trial, which compared healing results between those treated with Intact Fish Skin Graft plus standard care and those receiving only standard care. The study seeks to understand the rate of wound recurrence over time. The study observes patients who achieved ulcer closure during the THOR trial without providing new treatments. It follows these participants to monitor the durability of their healed wounds. No additional interventions are administered, as this is an observational follow-up. Participants will be followed for 12 months to assess the durability of closure, which is the primary outcome measured. Researchers will review the participants' wound status throughout this period to record any recurrence. The study involves periodic evaluations but does not include experimental treatments or procedures.
CONDITIONS
Brief Title
Evaluating the Durability of Closure for Venous Leg Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must have participated in the THOR trial and achieved complete closure by the 12-week endpoint.
You will not qualify if you...
- Subjects who did not participate in the THOR trial.
- Subjects who participated in the THOR trial and did not achieve complete closure.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants who have achieved wound closure in a previous trial are observed to evaluate the durability of their wound closure over time.
Trial Site Locations
Total: 1 location
1
Serena Group
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
Research Team
B
Bennett Rogers
T
Thomas Serena, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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