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FDAnews Device Daily Bulletin

Studies: DermaPACE Falls Short in Efficacy, but Superior at 24 Weeks

March 28, 2016

A study of Sanuwave Health’s dermaPACE, which is intended to treat diabetic foot ulcers, missed its 12-week efficacy endpoint in two 24-week trials comparing the device to Sham-control.

The device, however, prevailed at 20 to 24 weeks in one trial, exhibiting superiority in wound closure versus the control, the company says.

Although dermaPACE did not demonstrate superiority in the second study, its wound closure rate at 24 weeks was 35.4 percent compared with 26.2 percent in sham control. — Anisa Jibrell