The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which venous leg ulcers (VLU)n will be treated using Aurix and compared to patients receiving undefined Usual and Customary Care (UCC)
Recurrence of ulcers in the leg is common; two-thirds of patients are likely to experience recurring ulcers after the first ulcer. While treatment of the underlying venous disease, depending on the mode of treatment, can lower the recurrence rate in many patients, it does not affect recurrence. Aurix is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. The aim of this trial is to demonstrate the effectiveness, measured as complete wound healing, in a prospective, randomized trial in which venous leg ulcers will be treated using Aurix and standard of care and compared 1:1 to patients receiving undefined Usual and Customary Care (UCC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
640
Aurix is a platelet-rich plasma gel used in the treatment of non-healing wounds. It will be administered twice weekly for 2 weeks then weekly.
Time to Heal
Aurix plus standard of care versus usual and customary care only. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart (FDA Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment, 2006).
Time frame: 12 weeks
Proportion of wounds healed
Comparison of proportion of wounds healed over 12 weeks
Time frame: 12 weeks
Change in Quality of Life with Chronic Wounds (W-QOL) Score
Change in mean Quality of Life with Chronic Wounds (W-QOL) score between baseline and at 12 weeks
Time frame: 12 weeks
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