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

Status unconfirmed · Phase 2

Conditions studied: Plantar Fasciitis, Plantar Fasciitis, Chronic, Plantar Fasciitis of Both Feet

In brief

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.

Key facts

Study ID

NCT03978234

Run by

University Foot and Ankle Foundation

People needed

30

Starts

2019-11-20

Expected to finish

2021-12-31

Last updated by the study team

2020-09-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University Foot & Ankle Institute — Santa Monica, California, United States (enrolling)

Full record on ClinicalTrials.gov

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