NL-OMON55595已完成不适用
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 - HANDS O
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •- Known allergy for dyes used in textiles
- •- Known allergy for silver fibre
研究者
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