A Randomized Controlled Multicenter Clinical Trial Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers

Kerecis Ltd.1 site in 1 country150 target enrollmentNovember 25, 2024

ConditionsVenous Leg Ulcer (VLU)Venous Leg Ulcers Venous Leg Nonhealing Venous Leg Ulcer

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Venous Leg Ulcer (VLU)
Sponsor: Kerecis Ltd.
Enrollment: 150
Locations: 1
Primary Endpoint: The percentage of target ulcers achieving complete wound closure
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

This is a randomized controlled multicenter clinical trial evaluating intact fish skin grand and standard of care vs. standard of care alone in nonhealing venous leg ulcers. The product classifies as a medical device and consists of a full thickness fish-skin that has been processed using Kerecis™ Limited's proprietary EnviroIntact™ method.

Registry

clinicaltrials.gov

Start Date

November 25, 2024

End Date

November 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kerecis Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
•ABI between 0.7 and ≤ 1.3;
•TCOM ≥ 40 mmHg;
•PVR: biphasic.
•If the potential subject has two or more ulcers, and they are separated by at least 2 cm post-debridement, the largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer. If the potential subject has two or more ulcers and they are separated by less than 2cm, the entire wound area is designated as the target ulcer.
•Subjects must have a Functional Ambulatory Category Score (FACS) of 3 or greater.

Exclusion Criteria

•The potential subject is known to have a life expectancy of \< 6 months.
•The index ulcer is determined to be due to a condition other than venous insufficiency.
•The target ulcer exposes muscle, tendon, or bone.
•The target ulcer exhibits overt clinical signs and symptoms of infection with cellulitis surrounding the wound margin.
•The target ulcer has known or suspected skin malignancy.
•The target ulcer has been previously exposed to radiation.
•The target ulcer duration is greater than one year having received high level compression without closure for a year or more.
•The potential subject has end stage renal disease requiring dialysis.
•The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
•A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.

Outcomes

Primary Outcomes

The percentage of target ulcers achieving complete wound closure

Time Frame: [Time Frame: 1-12 Weeks]

The percentage of target ulcers achieving complete wound closure in 12 weeks

Secondary Outcomes

Time to closure([Time Frame: 1-12 weeks])
Percent area change([Time Frame: 1-12 weeks])
Adverse Events([Time Frame: 1-12 weeks])
Change in pain in target ulcer([Time Frame: 1-12 weeks])
Visits and product applications needed to close the ulcer([Time Frame: 1-12 weeks])
Quality of life using the Wound quality of Life questionare wQOL([Time Frame: 1-12 weeks])
Determine improvement in Quality of Life - Forgotten Wound Score FWS([Time Frame: 1-12 weeks])