DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

A Phase 2, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.

Inclusion Criteria:

• Written informed consent, including authorization to release health information
• Skeletally mature, male or female patients 18 to 65 years of age with diagnosis of plantar fasciitis
• Persistent heel pain for more than three months
• Women of child bearing potential must have a negative urine pregnancy test (UPT) at Screening Visit and must use an effective method of birth control during the course of the study

Exclusion Criteria:

• Previous surgery on the midfoot or hindfoot
• Neuromuscular disease
• Systemic muscle weakness
• Planning a pregnancy during the study
• Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit