Prospective, single-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis
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. The study is expected to be completed within 36 months, inclusive of enrollment and follow-up of all subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
147
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
Limb Preservation Platform, Inc.
Fresno, California, United States
Center for Clinical Research, Inc.
San Francisco, California, United States
20% improvement over baseline Visual Analog Scale for Pain
Visual Analog Scale
Time frame: 3 Months
Incidence of adverse events
Review AE at every visit
Time frame: 12 months
20% improvement in Foot Function Index-Revised (FFI-R) score from baseline
Foot Function Index
Time frame: 3 months
Blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm
Lab blood draws
Time frame: 3 and 12 months
Long-term FFI-R outcomes
Foot Function Index
Time frame: 6 and 12 months
Long-term Visual Analog Scale (VAS) Pain outcomes
Visual Analog Scale
Time frame: 6 and 12 months
Long-term blood sample analysis for immuno-compatibility of first 20 patients in each treatment arm
Lab blood draws
Time frame: 6 and 12 months
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Orlando VA Healthcare System
Orlando, Florida, United States
Edward Hines Jr. Veterans Administration Hospital
Chicago, Illinois, United States
James A. Lovell Federal Health Care Center
North Chicago, Illinois, United States
Timonium Foot and Ankle Center
Baltimore, Maryland, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, United States
WJB Dorn VA Medical Center
Columbia, South Carolina, United States
Scott & White Healthcare
Temple, Texas, United States
...and 1 more locations