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

What we are studying

The purpose of this research study is to compare the safety and efficacy of toxin injections versus placebo for managing plantar fasciitis that has not responded to other treatments. In this study DaxibotulinumtoxinA for Injection will be compared to placebo. A placebo is a substance, like a sugar pill, that is not thought to have any effect on your disease or condition. In this study you will either receive the active study medication or placebo which is not active. Placebos are used in research studies to see if the drug being studied really does have an effect.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18 - 65

Eligibility Criteria

  • Diagnosis of unilateral plantar fasciitis by physical examination and/or ultrasonography
  • Unilateral plantar fasciitis as defined as no symptoms or signs in the contralateral foot with no sought medical attention in the contralateral foot
  • Persistent heel pain for more than three months
  • Failure of conservative treatment including antiinflammatory medications Splinting Heel pads Stretching exercises And/Or steroid injections
  • 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
  • A 12 lead Electrocardiogram (ECG) within 6 months with a normal interpretation is required

What is involved

  • 7 clinic visits
  • Screening Visit
  • Injection visit
  • 1 week
  • 2 weeks
  • 4 weeks
  • 8 weeks
  • 16 weeks
  • Foot and ankle examinations
  • Questionnaires at each visit
  • 5-7 injections in the back of the leg and heel (at 2nd visit only) by ultrasound guidance
  • 3 lab visits (before injection 2 weeks after injection and 16 weeks after injection)

Compensation

$25 for completing 4 and 8 week visits, and $50 for completing the 16 week visit

Contact Information

Study Coordinator
J. Brett Goodman
Email
orthoresearch@wakehealth.edu
Phone
336-713-5150
Principal Investigator
Robert L. Sprinkle, D.P.M.

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.