Clinical Trial: Botulinum Toxin in the Treatment of Raynaud's

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Botulinum Toxin in the Treatment of Raynaud's

Brief Summary:

The investigators are studying a medical condition known as Raynaud's Phenomenon (RP). RP is a painful condition in which cold surroundings or stressful events trigger pain, a cold sensation, and in severe cases, sores and ulcers on one's fingers. The investigators think that RP results from problems with some of the components of the blood vessels, surrounding nerves, and some of the circulating messengers in the bloodstream. Although there are many different medicines that are currently used to treat RP, the investigators have not yet found a cure for severe cases of this condition. Furthermore, the investigators have found few medicines that show consistent healing of the ulcers that may be associated with RP. Some of the treatments include medicines that are used to treat high blood pressure known as calcium channel blockers. Medications that thin the blood (anticoagulants) such as aspirin have also been used to treat RP.

In this study, the investigators will investigate a new treatment for RP known as Botulinum toxin A. Botulinum toxin is a chemical that is temporarily toxic to nerves, but has been approved by the government for the treatment of several other conditions including but not limited to: excessive sweating, neck pain associated with a condition known as cervical dystonia, uncontrollable forcible closure of the eyelids known as blepharospasm, and a condition known as strabismus in which the eyes are not in alignment with one another.

This study will aim to greatly improve the quality of life and pain associated with RP. Previous studies also support the chance that Botulinum toxin will help to heal some of the ulcers associated with RP. Although there is no current standard of care, many of the patients in the study will have already failed or are unable to tolerate commonly used treatments such as lifestyl

Detailed Summary:
Sponsor: Emory University

Current Primary Outcome: Mean Digital Temperature Difference From Baseline [ Time Frame: 6 weeks ]

Each digit temperature was measured and recorded at baseline, and then measured and re-recorded after 3 minute intervals following a 20 second 4 degree Celsius ice bath immersion.


Original Primary Outcome: digital temperature [ Time Frame: 6 weeks ]

Each digit temperature will be measured at baseline, recorded and re-measured past 20 second immersion in 4 degree C water. Temperature will continued to be measured until return to baseline.


Current Secondary Outcome:

Original Secondary Outcome: Quality of Life [ Time Frame: 6 weeks ]

Eash participant will fill out Skindex29 questionnaire.


Information By: Emory University

Dates:
Date Received: November 2, 2010
Date Started: October 2010
Date Completion:
Last Updated: March 15, 2014
Last Verified: March 2014