A Two-Part Study of BOTOX® Therapy for Ischemic Digits
Status:
Completed
Trial end date:
2016-07-13
Target enrollment:
Participant gender:
Summary
Treating patients with Raynaud's phenomenon who have chronic pain and ulcerations is
extremely challenging. Published reports and our previous work support our hypothesis that
symptomatic patients experience relief of pain and healing of ulcerations with minimal
adverse effects when treated with botulinum toxin type A (Btx-A) injections for Raynaud's
phenomenon. The proposed study is the first clinical trial and prospective study designed to
document whether or not 1) Btx-A injection relieves pain in a patient's hand affected with
Raynaud's disease better than a placebo within 28 days of injection, and 2) Btx-A injection
relieves pain associated with Raynaud's disease for longer than 28 days, improving patients'
quality of life. Through this study we intend to further determine the effect of injected
Btx-A on relieving chronic pain and ulcerations to the ischemic hand while characterizing the
patients for whom this treatment is most effective.
Phase:
Phase 2
Details
Lead Sponsor:
Southern Illinois University
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA