Venous Leg Ulcers Clinical Trial
Official title:
A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in Venous Leg Ulcers
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). ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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