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

The purpose of this Study is to determine the efficacy (how well it works) of a cellular and tissue-based product (CTP) plus Standard of Care (SOC) versus SOC alone in achieving complete closure of hard-to-heal venous leg ulcers (VLU) over 12 weeks

Inova Fairfax Medical Center 
3300 Gallows Rd  
Falls Church, VA, 22042

•     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, must have a target ulcer with a minimum surface area of 1 cm² (0.155 in², or approximately the size of a pencil eraser) and a maximum surface area of 25 cm² (3.875 in², or approximately the size of a large watch face) measured post-debridement (removal of dead, damaged, or infected tissue from a wound to help it heal). 

• You are known to have a life expectancy of less than 6 months.
• Index ulcer is determined to be due to a condition other than venous insufficiency.
• Target ulcer exposes muscle, tendon, or bone.
• Target ulcer exhibits overt clinical signs and symptoms of infection with cellulitis (bacterial infection of the skin) surrounding the wound margin.
• You are 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 study doctor believes will interfere with wound healing (e.g., biologics).