Study of the effects of Botulinum Neurotoxin A injection on the treatment of chronic 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 conservative treatment. The study sponsor has developed a botulinum toxin product that has been named RT002 that has not been approved for this condition. RT002 is a botulinum toxin that has been studied for its use in cosmetics to treat wrinkles. The study performed showed no evidence of spread of the toxin through the body beyond the place where it was injected. Botulinum toxin has been studied in the treatment of plantar fasciitis, however, our study proposes adding an injection site with the hope that this will cause sustained rest of the inflamed plantar fascia in the same manner it causes sustained loss of wrinkles. In this study RT002 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, RT002 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 we are studying

  • Men and 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 anti-inflammatory 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
  • Injections
  • 1 week
  • 2 weeks
  • 4 weeks
  • 6 weeks
  • 16 weeks
  • 7 foot and ankle examinations
  • 6 questionnaires at each visit
  • 3 injections (at 2nd visit only) by Ultrasound Guidance
  • 3 lab visits
  • Before injection
  • 2 weeks after injection
  • 16 weeks after injection

Compensation

$25 for completing 4 and 6 week visits, and $50 for completing the 16 week visit

Contact Information

Study Coordinator
James Goodman
Email
orthoresearch@wakehealth.edu
Phone
3367135150
Principal Investigator
L. Andrew Koman, MD

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.