Clinical Trial: Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Prospective, Randomized, Controlled, Blinded, Comparative Study of Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar The primary objective of this study is to compare the efficacy of the different treatment amounts in reduction of inflammation as measured by AOFAS Hindfoot scores.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Return to normal activities more quickly than with standard of care [ Time Frame: 8 Weeks ]
    The secondary objective is to demonstrate that patients treated with micronized dHACM injectable will return to normal activities more quickly than with standard of care.
  • Pain as measured by 0-10 Numeric Rating Scale [ Time Frame: 12 weeks ]
    Patient pain scores will be assessed between all groups.


Original Secondary Outcome: Same as current

Information By: MiMedx Group, Inc.

Dates:
Date Received: October 10, 2013
Date Started: September 2013
Date Completion:
Last Updated: June 12, 2014
Last Verified: June 2014