NCT03978234
Unknown
Phase 2
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
University Foot and Ankle Foundation1 site in 1 country30 target enrollmentNovember 20, 2019
InterventionsAbobotulinumtoxinA 300 UNT
Overview
- Phase
- Phase 2
- Intervention
- AbobotulinumtoxinA 300 UNT
- Conditions
- Plantar Fasciitis
- Sponsor
- University Foot and Ankle Foundation
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- injection
- Last Updated
- 5 years ago
Overview
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.
Investigators
Maha K. Curley
Study Coordinator
University Foot and Ankle Foundation
Eligibility Criteria
Inclusion Criteria
- •At least 18 years old and not older than 75 years.
- •History of Plantar fasciitis for a minimum of 6 weeks
- •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)
- •Minimum Visual Analog Scale (VAS) score of
- •Failed conservative care with at least two of the following treatments: Stretching, rest, shoe modifications, insoles or orthotics, physical therapy, or cortisone injection.
- •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.
- •Subject understands and is willing to participate in the clinical study and can comply with visit and post -injection questionnaire schedules.
Exclusion Criteria
- •Patients with history of diabetes, back issues, nerve issues or previous surgery of the foot or calf.
- •Patients with no pain in the heel region.
- •Subject is pregnant or breast- feeding.
Arms & Interventions
Single group
Single group
Intervention: AbobotulinumtoxinA 300 UNT
Outcomes
Primary Outcomes
injection
Time Frame: 8 weeks
Reduction of pain (VAS scale) associated with plantar fasciitis at 8 weeks post injection
Secondary Outcomes
- Adverse Events(26 weeks)
- PROMIS Pain intensity instrument(26 weeks)
- PROMIS Pain interference instrument(26 weeks)
- PROMIS Physical function Instrument(26 weeks)
- AOFAS Ankle-Hindfoot Score(26 weeks)
- FAAM Foot and Ankle Ability Measure(26 weeks)
- Gastrocnemius measurement(26 weeks)
- Gastrocnemius measurement and mobility(26 weeks)
Study Sites (1)
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