Trial Board for Sanuwave’s DermaPace Requests More Data
The clinical trial board overseeing Sanuwave’s DermaPace diabetic foot ulcer treatment has requested to review more data after concluding the study likely will fail to meet its endpoint.
The study has a Phase III primary efficacy endpoint at 100 percent complete wound closure for 170 patients at 12 weeks, the company says.
The trial’s independent Data Monitoring Committee wants to see data from 20 weeks, noting that the device demonstrated positive efficacy at the 20-week endpoint during the first study of 206 patients concluded in 2011.
The company is deciding whether to stop the trial to use as supporting data for a PMA application later this year or to continue as planned.
In 2011, the FDA sent the devicemaker a “major deficiency” letter requesting the company launch another DermaPace trial.
DermaPace uses shockwave technology to heal diabetic foot ulcers and increase limb preservation. — Jason Scott