To assess the efficacy of the PRP Concepts Fibrin Bio-Matrix and compare its performance with usual and customary practice for the treatment of chronic non-healing venous leg ulcers (VLU).
This is a prospective, randomized, single-blind, controlled, multi-center study for subjects undergoing VLU treatment. Qualified subjects will be randomized (1:1); test group (PRP Concepts Fibrin Bio-Matrix) and control group (usual and customary practice). The study will consist of 3 periods: a screening period, an active treatment period, and a follow-up period (if healed). Approximately 250 subjects will be enrolled. Subjects will be ≥18 years of age with a VLU (greater than 4 weeks duration). Each subject will be enrolled in the active treatment period for up to 12 weeks, or to closure of wound with a confirmatory visit 2 weeks after wound closure, whether such closure occurs at 12 weeks or earlier.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice
Usual and Customary Practice for non-healing venous leg ulcers
Westchester General Hospital
Miami, Florida, United States
RECRUITINGTime to complete wound closure
Complete wound closure is defined as full epithelialization of the wound with the absence of drainage, durability confirmed at 2 weeks
Time frame: 12 weeks
Percent of wounds healed
Percent of wounds healed at 12 weeks
Time frame: 12 weeks
Wound Trajectory
Mean and median of percent (%) wound size changes at 4 weeks, 8 weeks and 12 weeks
Time frame: 12 weeks
Ulcer recurrence
Ulcer recurrence out to 3 months for subjects whose wounds heal by conclusion of 12 weeks visit.
Time frame: 3 months
Quality of Life Health Survey
Changes in Quality of Life scores and ability to return to previous function/resumption of normal activities
Time frame: 3 months
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