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

Sponsor

University Foot and Ankle Foundation (Other)

Overall Status

Recruiting

CT.gov ID

NCT03978234

Collaborator

(none)

Enrollment

Location

Arm

25.4

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Plantar Fasciitis Plantar Fasciitis, Chronic Plantar Fasciitis of Both Feet	Drug: AbobotulinumtoxinA 300 UNT	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 20, 2019

Anticipated Primary Completion Date :

Oct 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Single group

Single group

Drug: AbobotulinumtoxinA 300 UNT

AbobotulinumtoxinA 300 UNT

Outcome Measures

Primary Outcome Measures

injection [8 weeks]
Reduction of pain (VAS scale) associated with plantar fasciitis at 8 weeks post injection

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 4.
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.