Sanuwave Health announced positive results from its Phase 3 study of dermaPACE for the treatment of diabetic foot ulcers. The 206-patient, randomized, double-blinded, parallel-group, sham-controlled, multicenter, 24-week pivotal clinical trial was designed to quantify the safety and effectiveness of four, 20-minute, noninvasive procedures with dermaPACE, delivered over a 2-week period comparing dermaPACE with Sham-control (non-active treatment) when both are combined with the current standard of care.
The primary efficacy endpoint of complete wound closure reached statistical significance at Week 20 in the intent-to-treat (ITT) population with 36% of dermaPACE subjects achieving complete wound closure compared with 23% of Sham-control subjects (P=0.047). In the Efficacy Evaluable (EE) population, 38% of dermaPACE subjects achieved complete wound closure beginning at Week 20, compared with 21% of Sham-control subjects (P=0.018). At Week 24, dermaPACE achieved 40% complete wound closure in the ITT population (P=0.054) and 41% complete wound closure in the EE population (P=0.022).
PACE, defined as Pulsed Acoustic Cellular Expression, delivers high-energy acoustic pressure waves in the shock wave spectrum to produce compressive and tensile stresses on cells and tissue structures to promote angiogenic and positive inflammatory responses, and quickly initiate the healing cascade. This results in revascularization and microcirculatory improvement, including the production of angiogenic growth factors, enhanced new blood vessel formation (angiogenesis), and the subsequent regeneration of tissue such as skin, musculoskeletal and vascular structures.
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