drugset / Trial / NCT03978234

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

NCT03978234 ↗

Phase 2 Unknown 30 enrolled University Foot and Ankle Foundation
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-11-20
Primary completion
2021-10-31
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 300 unknown Intramuscular

Indications