Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers

Recruiting Phase 4 Interventional Study
Venous Leg Ulcer (VLU) Venous Leg Ulcers Venous Leg Nonhealing Venous Leg Ulcer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Kerecis Ltd. · Industry
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About This Trial

The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of hard-to-heal venous leg ulcers (VLU) between Intact Fish Skin Graft plus standard of care (IFSG/SOC) versus standard of care alone (SOC) over 12 weeks.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Subjects must be at least 18 years of age or older. 2. Subjects must have a nonhealing venous leg ulcer present for a minimum of 4 weeks and cannot have received more than 52 weeks of high-level compression prior to the initial screening visit. 3. No visible signs of healing …
Contacts

Barkley Booker

888-960-1343

bbooker@serenagroups.com

CONTACT

Thomas Serena, MD

814-688-4000

serena@serenagroups.com

CONTACT