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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Intact Fish Skin Graft (IFSG) + Standard of Care
Other interventionParticipants will receive weekly applications of MariGen and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Standard of Care
Other interventionBeginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Intact Fish Skin Graft (IFSG) + Standard of CareExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The percentage of target ulcers achieving complete wound closure
The percentage of target ulcers achieving complete wound closure in 12 weeks
Time frame
[Time Frame: 1-12 Weeks]Secondary outcomes
1
Time to closure
The time to closure of the target ulcers over 12 weeks.
Time frame
[Time Frame: 1-12 weeks]2
Percent area change
Percentage wound area change from TV-1 to TV-13 measured weekly with digital photographic planimetry and physical examination.
Time frame
[Time Frame: 1-12 weeks]3
Adverse Events
The number of adverse events.
Time frame
[Time Frame: 1-12 weeks]4
Change in pain in target ulcer
Change in pain in the target ulcer assessed using the Visual Analog Scale VAS scale from TV-1 to TV-13
Time frame
[Time Frame: 1-12 weeks]Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kerecis Ltd.
Lead sponsor
Serena Group
Collaborator
Source ClinicalTrials.gov