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

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

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 Overview

• Status: Unknown
• Conditions: Plantar Fasciitis; Plantar Fasciitis, Chronic; Plantar Fasciitis of Both Feet
• Intervention / Treatment: Drug: AbobotulinumtoxinA 300 UNT

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Maha K Curley, CRC; Phone Number: 1007 310-828-0011; Email: mahak@footankleinstitute.com

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90403
      • Recruiting
      • University Foot & Ankle Institute
      • Contact: Maha K. Curley, CRC; Email: mahak@footanklesintitute.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single group	Drug: AbobotulinumtoxinA 300 UNT; AbobotulinumtoxinA 300 UNT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
injection	Reduction of pain (VAS scale) associated with plantar fasciitis at 8 weeks post injection	8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Foot and Ankle Foundation
• Investigators: Principal Investigator: Babak Baravarian, DPM, University Foot & Ankle Foundation

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Heel pain; Plantar Fasciitis
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: UFAI-PF-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No