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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.
Corticosteroids are considered a standard of care for treatment of Plantar Fasciitis
Advanced Orthopedics
Denver, Colorado, United States
Orlando Food and Ankle Clinic
Orlando, Florida, United States
The Iowa Clinic Foot and Ankle Surgery
West Des Moines, Iowa, United States
Lower Extremity Institute of Research & Therapy (LEIRT)
Poland, Ohio, United States
Change in AOFAS score from baseline
Time frame: 6 months
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
Assessed using questionnaire by the Principal Investigator (PI)
Time frame: 6 months
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Geisinger
Danville, Pennsylvania, United States
The Vancouvover Clinic
Vancouver, Washington, United States