Clinical Trial: ReNu™ vs. Corticosteroids for the Treatment of Plantar Fasciitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Comparative Study of Injectable Human Amniotic Allograft (ReNu™) Versus Corticosteroids for Plantar Fasciitis: A Prospective, Randomized, Blinded Study
Brief Summary: The objective of this clinical trial is to evaluate both the safety and efficacy of the ReNu™ injection on pain and inflammation in subjects diagnosed with plantar fasciitis as compared to a Corticosteroid Injection which is considered standard of care.
Detailed Summary:
This is a two (2) arm evaluation in 150 subjects with plantar fasciitis. Patients will be treated with ReNu™(study treatment) or Corticosteroids (control).
At each follow-up visit, concomitant medications and adverse events shall be collected from each subject, and each subject shall complete following questionnaires:
- AOFAS Ankle-Hindfoot Score (AOFAS-AHS)
- Visual Analog Score (VAS)
- Single Answer Numeric Evaluation (SANE)
- Subject Satisfaction Score (at the 6 Month Follow Ups ONLY)
The subjects will be assessed at Baseline (pre-injection) using these scales and again at all subsequent study follow-up visits.
Sponsor: NuTech Medical, Inc
Current Primary Outcome: Change in AOFAS score from baseline [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in VAS pain score from baseline [ Time Frame: 6 months ]
- Change in SANE function score from baseline [ Time Frame: 6 months ]
- Return to Normal Function between treatment groups [ Time Frame: 6 months ]Assessed using questionnaire by the Principal Investigator (PI)
Original Secondary Outcome: Same as current
Information By: NuTech Medical, Inc
Dates:
Date Received: November 29, 2016
Date Started: October 2016
Date Completion: December 2017
Last Updated: December 8, 2016
Last Verified: November 2016
