Evaluating the Safety and Effect of abobotulinumtoxinA in the Gastrocnemius Muscle to Improve Equinus and Plantar Fasciitis Pain

Phase 2

• Conditions: Plantar Fasciitis; Plantar Fasciitis, Chronic; Plantar Fasciitis of Both Feet
• Interventions: Drug: AbobotulinumtoxinA 300 UNT

• Registration Number: NCT03978234
• Lead Sponsor: University Foot and Ankle Foundation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-07
• Study Start: 2019-11-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-22
• Last Update Posted: 2020-09-24
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single group	AbobotulinumtoxinA 300 UNT	Single group

Primary Outcome Measures

Name	Time	Method
injection	8 weeks	Reduction of pain (VAS scale) associated with plantar fasciitis at 8 weeks post injection

Secondary Outcome Measures

Name	Time	Method
Adverse Events	26 weeks	Number of product related AEs per patient that are definitely, probably, or possibly related to the product post-injection
PROMIS Pain intensity instrument	26 weeks	Changes in PROMIS Pain Intensity Instrument,
PROMIS Pain interference instrument	26 weeks	Changes in PROMIS Pain Interference Instrument
PROMIS Physical function Instrument	26 weeks	Changes in PROMIS Physical function instrument
AOFAS Ankle-Hindfoot Score	26 weeks	Changes in the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
FAAM Foot and Ankle Ability Measure	26 weeks	Changes in the Foot and Ankle Ability Measure
Gastrocnemius measurement	26 weeks	Changes in gastrocnemius muscle size using ultrasonography
Gastrocnemius measurement and mobility	26 weeks	Changes in gastrocnemius range of motion/dorsiflexion using goniometer

Trial Locations

Locations (1)

University Foot & Ankle Institute; 🇺🇸 Santa Monica, California, United States