Fasciitis, Plantar Clinical Trial
Official title:
A Comparative Study of Injectable Human Amniotic Allograft (ReNu™) Versus Corticosteroids for Plantar Fasciitis: A Prospective, Randomized, Blinded Study
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.
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.
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