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临床试验/NCT01233999
NCT01233999已完成不适用

Botulinum Toxin in the Treatment of Raynaud's

Emory University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Mean Digital Temperature Difference From Baseline

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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. -

排除标准

  • 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.

研究组 & 干预措施

Botox

Placebo Comparator

single-drug dosage comparison cross-over study

干预措施: botulinum toxin A (Drug)

结局指标

主要结局

Mean Digital Temperature Difference From Baseline

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suephy Chen, MD

Associate Professor

Emory University

研究点 (1)

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