Diabetic Foot Ulcers Clinical Trial
Official title:
A Double-Blind, Multi-center, Randomized, Sham-Controlled, Parallel Group Comparison of the dermaPACE® (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care Versus Standard of Care Alone in the Treatment of Diabetic Foot Ulcers
The Sponsor of this study, SANUWAVE, Inc., has developed an investigational device known as
the dermaPACE® (Pulsed Acoustic Cellular Expression) device for the possible treatment of
diabetic foot ulcers. This device generates acoustic (sound) pressure waves designed to act
on the cells in your body to generate proteins that may lead to wound closure. The
dermaPACE® device has not been approved for the treatment of diabetic foot ulcers; therefore
its use in this study is investigational.
The purpose of the study is to evaluate the ability of the dermaPACE® device to help
diabetic foot ulcers heal more quickly. The active study device, the dermaPACE®, will be
compared to an inactive look-alike device (called a "Sham") in this study. The sham device
will not provide any treatment to your diabetic foot ulcer.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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