NCT03978234

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Foot and Ankle Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	AbobotulinumtoxinA 300 UNT	AbobotulinumtoxinA 300 UNT

Timeline

• Start date: 2019-11-20
• Primary completion: 2021-10-31
• Completion: 2021-12-31
• First posted: 2019-06-07
• Last updated: 2020-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study