Clinical Trial: Micronized dHACM Injectable for the Treatment of Plantar Fasciitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Prospective, Single-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to the Saline Placebo Injection in the Treatment of Plantar Fasciitis
Brief Summary: Prospective, single-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis
Detailed Summary: Approximately 146 patients will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 12-month observation period with an additional evaluation at 24 months. The study is expected to be completed within 36 months, inclusive of enrollment and follow-up of all subjects.
Sponsor: MiMedx Group, Inc.
Current Primary Outcome:
- 20% improvement over baseline Visual Analog Scale for Pain [ Time Frame: 3 Months ]
- Incidence of adverse events [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 20% improvement in Foot Function Index-Revised (FFI-R) score from baseline [ Time Frame: 3 months ]
- Blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm [ Time Frame: 3 and 12 months ]
- Long-term FFI-R outcomes [ Time Frame: 24 months ]
- Long-term VAS Pain outcomes [ Time Frame: 24 months ]
- Long-term blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm [ Time Frame: 24 months ]
Original Secondary Outcome: Same as current
Information By: MiMedx Group, Inc.
Dates:
Date Received: April 22, 2015
Date Started: March 2015
Date Completion: July 2017
Last Updated: February 17, 2017
Last Verified: February 2017
