Clinical trial NCT03978234: Evaluating the Safety and Effect of abobotulinumtoxinA in the Gastrocnemius Muscle to Improve Equinus and Plantar Fasciitis Pain
Official title: A Phase II Clinical Trial Evaluating the Safety and Effect of abobotulinumtoxinA Injection in the Gastrocnemius Muscle to Improve Equinus and Associated Plantar Fasciitis Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Plantar Fasciitis
Plantar Fasciitis, Chronic
Plantar Fasciitis of Both Feet
Keywords: Heel pain
Plantar Fasciitis
Lead sponsor: University Foot and Ankle Foundation
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years old and not older than 75 years.
2. History of Plantar fasciitis for a minimum of 6 weeks
3. History and physical examination consistent with plantar fasciitis and a diagnostic ultrasound study showing thickening of the plantar fascia \>5 mm (normal is 3 mm)
4. Minimum Visual Analog Scale (VAS) score of 4.
5. Failed conservative care with at least two of the following treatments: Stretching, rest, shoe modifications, insoles or orthotics, physical therapy, or cortisone injection.
6. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
7. Subject understands and is willing to participate in the clinical study and can comply with visit and post -injection questionnaire schedules.

Exclusion Criteria:

1. Patients with history of diabetes, back issues, nerve issues or previous surgery of the foot or calf.
2. Patients with no pain in the heel region.
3. Subject is pregnant or breast- feeding.

Primary outcomes:
measure: injection
timeFrame: 8 weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: 26 weeks
measure: PROMIS Pain intensity instrument
timeFrame: 26 weeks
measure: PROMIS Pain interference instrument
timeFrame: 26 weeks
measure: PROMIS Physical function Instrument
timeFrame: 26 weeks
measure: AOFAS Ankle-Hindfoot Score
timeFrame: 26 weeks
measure: FAAM Foot and Ankle Ability Measure
timeFrame: 26 weeks
measure: Gastrocnemius measurement
timeFrame: 26 weeks
measure: Gastrocnemius measurement and mobility
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: University Foot & Ankle Institute
state: California
Study officials:
affiliation: University Foot & Ankle Foundation
name: Babak Baravarian, DPM
role: PRINCIPAL_INVESTIGATOR
References: