The purpose of this research is to collect safety and efficacy data on injection of botulinumtoxinA (AbobotulinumtoxinA /Dysort) into the gastrocnemius (calf) muscle to improve equinus (lack of flexibility to bring the top of the foot towards the front of the leg) in subjects with plantar fasciitis and relieve pain associated with this condition. The use of AbobotulinumtoxinA is considered experimental in this study because it has not been approved by the United States Food and Drug Administration (FDA) for the treatment of plantar fasciitis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
AbobotulinumtoxinA 300 UNT
University Foot & Ankle Institute
Santa Monica, California, United States
RECRUITINGinjection
Reduction of pain (VAS scale) associated with plantar fasciitis at 8 weeks post injection
Time frame: 8 weeks
Adverse Events
Number of product related AEs per patient that are definitely, probably, or possibly related to the product post-injection
Time frame: 26 weeks
PROMIS Pain intensity instrument
Changes in PROMIS Pain Intensity Instrument,
Time frame: 26 weeks
PROMIS Pain interference instrument
Changes in PROMIS Pain Interference Instrument
Time frame: 26 weeks
PROMIS Physical function Instrument
Changes in PROMIS Physical function instrument
Time frame: 26 weeks
AOFAS Ankle-Hindfoot Score
Changes in the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
Time frame: 26 weeks
FAAM Foot and Ankle Ability Measure
Changes in the Foot and Ankle Ability Measure
Time frame: 26 weeks
Gastrocnemius measurement
Changes in gastrocnemius muscle size using ultrasonography
Time frame: 26 weeks
Gastrocnemius measurement and mobility
Changes in gastrocnemius range of motion/dorsiflexion using goniometer
Time frame: 26 weeks
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