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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Participants will receive weekly applications of MariGen and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Beginning 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.
Serena Group- Monroeville
Monroeville, Pennsylvania, United States
RECRUITINGThe 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]
Time to closure
The time to closure of the target ulcers over 12 weeks.
Time frame: [Time Frame: 1-12 weeks]
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]
Adverse Events
The number of adverse events.
Time frame: [Time Frame: 1-12 weeks]
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]
Visits and product applications needed to close the ulcer
The number of visits and product applications needed to close the ulcer
Time frame: [Time Frame: 1-12 weeks]
Quality of life using the Wound quality of Life questionare wQOL
Change in quality of life using the wQOL checklist \[TV-1, TV-4, TV-8, and TV-12/Final Visit\].
Time frame: [Time Frame: 1-12 weeks]
Determine improvement in Quality of Life - Forgotten Wound Score FWS
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Quality of Life assessed using the Forgotten Wound Score. The scale has a score of 0 to 100- 100 being the worst outcome meaning the wound bothers the subject most of the time. \[TV-1, TV-4, TV-8, and TV-12/Final Visit\].
Time frame: [Time Frame: 1-12 weeks]