Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
- Conditions
- Plantar Fasciitis
- Interventions
- Biological: PlaceboBiological: Botulinum Toxins, Type A
- Registration Number
- NCT03137407
- Lead Sponsor
- Revance Therapeutics, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- Written informed consent, including authorization to release health information
- Male or female subjects 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 negative pregnancy test at Screening and Injection Visits and must use an effective method of birth control during the course of the study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Intramuscular Injection DAXI 240 U Botulinum Toxins, Type A DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U
- Primary Outcome Measures
Name Time Method Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot Week 8 The primary efficacy endpoint, as identified in the Statistical Analysis Plan (SAP) was the change from baseline in the visual analog scale (VAS) for pain for the affected foot at Week 8.
The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16 Weeks 1, 2, 4, 8, and 16 Reduction in foot pain was assessed as the change from baseline in the Visual Analog Scale (VAS) at weeks 1, 2, 4, 8, and 16. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.
Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS) Weeks 1, 2, 4, 8, and 16 The American Orthopaedic Foot and Ankle Score (AOFAS) measures foot and ankle conditions in 3 categories, pain, function, and alignment. The scale includes 9 items and the total score ranges from a minimum of 0 to a maximum of 100, with higher scores indicating a better outcome.
Change From Baseline Through Week 16 for the Foot and Ankle Disability Index Weeks 1, 2, 4, 8, and 16 The Foot and Ankle Disability Index is a 26 item questionnaire that measures disability and measures a total value minimum of 0 to a maximum of 104, with higher scores indicating greater disability.
Trial Locations
- Locations (5)
Village Podiatry Centers
🇺🇸Duluth, Georgia, United States
Weil Foot and Ankle Institute
🇺🇸Des Plaines, Illinois, United States
Kansas City Bone & Joint Clinic
🇺🇸Overland Park, Kansas, United States
Element Research Group
🇺🇸San Antonio, Texas, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States