SIU School of Medicine

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A Two-Part Study of BOTOX® Therapy for Ischemic Digits

IRB Number

12-187

ClinicalTrials.gov Identifier

NCT01309802

Trial Status

Open for Enrollment
Phase 2

Why is this study being done?

The purpose of this study is to examine the short- and long-term efficacy of botulinum toxin type-A (BOTOX®, Allergan, Inc.) in relieving pain and other complications due to Raynaud’s disease/phenomenon.

Who is eligible to participate?

Males and females, 18-75 years of age with pain, chronic ulcers, and/or perfusion problems, due to digital ischemia caused by Raynaud’s disease/phenomenon; have had or are willing/able to get an ultrasound or angiogram to demonstrate digit ischemia not due to peripheral artery disease or another vascular disease; and have up-to-date tetanus immunizations.

What is involved?

All participants will have a medical history and physical exam, complete questionnaires about hand function and quality of life, receive a digit transcutaneous oxygen saturation test (non-invasive measurement of the oxygen level of the fingers), have photos taken of the affected hand(s), and complete follow-up appointments. Participants will be randomized and given either BOTOX® or a placebo (saline) at the first appointment. After 28 days, participants who receive the placebo can receive BOTOX®, and those participants with persistent complications relating to Raynaud’s disease/phenomenon may receive additional treatment during the first year.

How long is the study?

The study is a long-term follow-up study in which the participants will be contacted several times over 5 years to see how long the effects of BOTOX® injection(s) last.

Who can I contact for additional information?

Please contact Jennifer Koechle, MPH, at (217) 545-7014 or email jkoechle@siumed.edu

Who is the Principal Investigator of this study?

Michael W. Neumeister, MD

Where is the trial located?

Springfield, Illinois