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

Plantar Fasciitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03978234
• Other study ID #: UFAI-PF-01
• Status: Recruiting
• Phase: Phase 2
• Start date: November 20, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2020
• Source: University Foot and Ankle Foundation
• Contact: Maha K Curley, CRC
• Phone: 310-828-0011
• Email: mahak[@]footankleinstitute.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis
• Plantar Fasciitis of Both Feet
• Plantar Fasciitis, Chronic

Intervention

Drug:
• AbobotulinumtoxinA 300 UNT
AbobotulinumtoxinA 300 UNT

Locations

Country	Name	City	State
United States	University Foot & Ankle Institute	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
University Foot and Ankle Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	injection	Reduction of pain (VAS scale) associated with plantar fasciitis at 8 weeks post injection	8 weeks
Secondary	Adverse Events	Number of product related AEs per patient that are definitely, probably, or possibly related to the product post-injection	26 weeks
Secondary	PROMIS Pain intensity instrument	Changes in PROMIS Pain Intensity Instrument,	26 weeks
Secondary	PROMIS Pain interference instrument	Changes in PROMIS Pain Interference Instrument	26 weeks
Secondary	PROMIS Physical function Instrument	Changes in PROMIS Physical function instrument	26 weeks
Secondary	AOFAS Ankle-Hindfoot Score	Changes in the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score	26 weeks
Secondary	FAAM Foot and Ankle Ability Measure	Changes in the Foot and Ankle Ability Measure	26 weeks
Secondary	Gastrocnemius measurement	Changes in gastrocnemius muscle size using ultrasonography	26 weeks
Secondary	Gastrocnemius measurement and mobility	Changes in gastrocnemius range of motion/dorsiflexion using goniometer	26 weeks

External Links

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