Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorKerecis Ltd.
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.
Eligibility criteria
Qualifiers
Subjects must be at least 18 years of age or older.
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.
No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.
At randomization, subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 25 cm2 measured post-debridement.
Disqualifiers
Subjects must have a Functional Ambulatory Category Score (FACS) of 3 or greater.
Subjects must consent to using the prescribed compression method for the duration of the study.
Subjects must agree to attend the weekly study visits required by the protocol.
Subjects must be willing and able to participate in the informed consent process.
Trial design
Treatments tested in this trial
- Intact Fish Skin Graft (IFSG) + Standard of Care
- Standard of Care
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Kerecis Ltd.
Lead sponsor
Serena Group
Collaborator
Source ClinicalTrials.gov