Sanuwave Health has presented positive data from its Phase III clinical trial of dermaPACE, used as a treatment for diabetic foot ulcers.
Pulsed acoustic cellular expression (PACE) delivers high-energy acoustic pressure waves to produce compressive and tensile stresses on cells and tissue structures to promote healing cascade.
In the trial, dermaPACE subjects reported 100% wound closure compared with sham control beginning at 20 weeks and continuing through to 24 weeks.
It is also found that dermaPACE considerably reduced the size of the target ulcer and lowered rate of ulcer recurrence.
Principal investigator of the trial Robert Frykberg said the pivotal Phase III clinical trial suggested that dermaPACE has an effect on the stabilisation, size reduction and time to complete closure of diabetic foot ulcers.
''Pending US Food and Drug Administration approval, the availability and utilisation of dermaPACE has the potential to positively impact the way we treat diabetic foot ulcers, and may bring us closer to our goal of improving wound outcomes through primarily cost-effective, clinically efficient pathways," Frykberg said.