Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis
Approximately 158 subjects 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. Randomization will be 1:1. The study is expected to be completed in 24 months, inclusive of enrollment and follow-up of all subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
146
1 mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM).
Injection of 1mL 0.9% Sodium Chloride Injection, USP
Central Research Associates
Birmingham, Alabama, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
ILD Research Center
Carlsbad, California, United States
Change in VAS score
Visual Analog Scale, Left end point is "No Pain". Right end point is "worst pain imaginable"
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: 365 days
Foot Function Index Revised (FFI-R) (Short Form)
Subjects circle the number that correlates how bad their foot pain was in certain situation.
Time frame: 90 days
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Foot and Ankle Clinic
Los Angeles, California, United States
Five Cities Foot Clinic
Pismo Beach, California, United States
South Florida Veterans Affairs
Miami, Florida, United States
Doctors Research Network
Miami, Florida, United States
Northside Podiatry
Buford, Georgia, United States
Foot and Ankle Center of Illinois
Springfield, Illinois, United States
Advanced Foot & Ankle Center
Las Vegas, Nevada, United States
...and 4 more locations