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Completed

NCT Number: NCT03137407

Phase 2 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.

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Key information

Conditions

Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Village Podiatry Centers, Duluth, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Botulinum Toxins, Type A

Biological

Intramuscular injection

Other names: DaxibotulinumtoxinA

Placebo

Biological

Intramuscular injection

Primary outcomes

  1. Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot

    Time frame: 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 outcomes

  1. Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16

    Time frame: 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.

  2. Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)

    Time frame: 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.

  3. Change From Baseline Through Week 16 for the Foot and Ankle Disability Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Revance Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 2, 2017
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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