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.
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.
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.
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.
Please contact Jennifer Koechle, MPH, at (217) 545-7014 or email firstname.lastname@example.org
Michael W. Neumeister, MD