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
- Conditions
- 10003816sclerodermaRaynauds phenomenon
- Registration Number
- NL-OMON55595
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 85
-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
- 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 fibre
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoints of this study are the Raynaud Condition Score and the VAS<br /><br>for burden caused by Raynaud*s. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include frequency and duration of Raynaud*s attacks and a<br /><br>VAS for warmth of the hands as documented by the patients in a web-based log,<br /><br>the degree of microangiopathy as assessed by Nailfold Capillary Microscopy<br /><br>(NCM), the number of incident digital ulcers (DU) and the Scleroderma Health<br /><br>Assessment Questionnaire (SHAQ). </p><br>