MiMedx initiated a Phase III study to evaluate AmnioFix Injectable vs. placebo in the treatment of Plantar Fasciitis.
The company submitted an Investigational New Drug amendment to FDA requesting the trial based on interim results of a previous IND Phase IIB trial.
The 18-month prospective, double-blind, randomized controlled trial will compare AmnioFix to saline injection in patients who have failed treatment for at least one month. Enrollment of ~165 patients will begin within 30 to 60 days.
Source: MiMedx Group Inc.