This is a prospective, controlled, randomized, blinded and comparative, single-center clinical trial comparing the improvement of patients with recalcitrant plantar fasciitis symptoms that have received standard of care versus treatment with differing amounts of injectable dehydrated human amnion/chorion membrane micrografts(dHACM).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
14
Injection of 1.0 cc of 0.9% Saline into affected area
Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension into affected area
Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension into affected area
Professional Education and Research Institute
Roanoke, Virginia, United States
Reduction of inflammation as measured by AOFAS Hindfoot scores
The primary objective of this study is to compare the efficacy of the different treatment amounts in reduction of inflammation as measured by AOFAS Hindfoot scores.
Time frame: 8 Weeks
Return to normal activities more quickly than with standard of care
The secondary objective is to demonstrate that patients treated with micronized dHACM injectable will return to normal activities more quickly than with standard of care.
Time frame: 8 Weeks
Pain as measured by 0-10 Numeric Rating Scale
Patient pain scores will be assessed between all groups.
Time frame: 12 weeks
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Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension into affected area