Prospective, double-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis
Approximately 276 patients will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 6-month observation period. Randomization will be 1:1. The study is expected to be completed within 34 months, inclusive of enrollment and follow-up of all subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
208
1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)
Injection of 1mL 0.9% Sodium Chloride Injection, USP
Southern Arizona VA Health Care System
Tucson, Arizona, United States
ILD Research Center
Carlsbad, California, United States
Change in VAS score
Visual Analog Scale for Pain:
Time frame: 90 Days
Incidence of adverse events
The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection
Time frame: 180 Days
Foot Function Index - Revised (FFI-R) (Short Form)
Foot Function Index - Revised: Patient Reported Questionnaire
Time frame: 90 Days
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Center for Clinical Research
Carmichael, California, United States
Limb Preservation Platform, Inc.
Fresno, California, United States
Horizon Clinical Research
La Mesa, California, United States
Foot and Ankle Clinic
Los Angeles, California, United States
Five Cities Foot Clinic
Pismo Beach, California, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, United States
Gulfcoast Research Institute, LLC
Sarasota, Florida, United States
Doctors Research Network
South Miami, Florida, United States
...and 7 more locations