NL-OMON20637尚未招募不适用
A randomised controlled trial to evaluate the effect of gloves containing silver fibre on burden caused by Raynaud’s phenomenon in patients with systemic sclerosis
eiden University Medical Center, Haga hospital The Hague, Maasstad Rotterdam.0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
研究概览
简要总结
.A.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Age = 18 years
- •-Diagnosis of Systemic sclerosis according to ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) 2013 classification criteria (total score of = 9, including a score of 3 for the RP item)
- •-Raynaud’s attack frequency of at least 4 attacks per week on = 3 different days and a Raynaud Condition score (RCS) at baseline of at least 34 (on a scale of 0-100)
- •-Vasoactive medication (Ca antagonists, ERA, PDE5 inhibitors) should be stable in the 2 weeks prior to the start of the trial
- •-Written informed consent
排除标准
- •-Past history of sympathectomy for Raynaud’s phenomenon
- •-Current treatment with iloprost, or iloprost infusion < 6 weeks prior to screening
- •-Known allergy for dyes used in textiles
- •-Known allergy for silver
研究者
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