Clinical trial NCT01233999: Botulinum Toxin in the Treatment of Raynaud's
Official title: Botulinum Toxin in the Treatment of Raynaud's
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Raynaud's Syndrome
Keywords: Scleroderma
Raynaud's Syndrome
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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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Primary outcomes:
measure: Mean Digital Temperature Difference From Baseline
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Suephy C Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: