NL-OMON55595
Completed
N/A
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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Raynauds phenomenon
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 85
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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