Botulinum Toxin in the Treatment of Raynaud's
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 5/3/2014 |
| Start Date: | October 2010 |
| End Date: | October 2011 |
| Contact: | Bridget Bradley, RN, FNP, CCRC |
| Email: | brbradl@gmail.com |
| Phone: | 404-778-3084 |
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 lifestyle modifications, calcium channel blockers, nitroglycerin, and
anticoagulants. If the patient chooses to participate in the study, he/she will be randomly
assigned to receive an injection with Botulinum toxin in either the left or right hand. The
other hand will be injected with saline solution. Neither the patient nor the physician or
research personnel seen in follow-up will know which hand is injected with Botulinum toxin.
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 lifestyle modifications, calcium channel blockers, nitroglycerin, and
anticoagulants. If the patient chooses to participate in the study, he/she will be randomly
assigned to receive an injection with Botulinum toxin in either the left or right hand. The
other hand will be injected with saline solution. Neither the patient nor the physician or
research personnel seen in follow-up will know which hand is injected with Botulinum toxin.
Inclusion Criteria:Adult (>18 years) patients with severe RP of any etiology will be
invited to participate. Inclusion criteria include a) history of digital infarcts or
ulcerations, b) unresponsive to standard therapies, or c) impending potential for digital
amputation. Patients on other standard therapies such as antiplatelet agents,
vasodilators, and calcium channel blockers will be included. -
Exclusion Criteria:Pregnancy, mild disease, patients with myasthenia gravis, botulinum
toxin allergy, and phobia of needles are exclusion criteria. Women of childbearing age
will need to demonstrate a negative urine pregnancy test. Myasthenia gravis is excluded
because underlying generalized weakness can be exacerbated, and local weakness at
injection sites can occur more than otherwise expected.
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Emroy University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Emroy University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
Click here to add this to my saved trials