The effect of gloves containing silver fibre on burden caused by Raynaud’s phenomenon in patients with systemic sclerosis

• Registration Number: NL-OMON20637
• Lead Sponsor: eiden University Medical Center, Haga hospital The Hague, Maasstad Rotterdam.

Brief Summary

.A.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 80

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 screening
-Known allergy for dyes used in textiles
-Known allergy for silver

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoints of this study are the Raynaud Condition Score and the VAS for burden caused by Raynaud’s.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints include frequency and duration of Raynaud’s attacks and a VAS for warmth of the hands as documented by the patients in a web-based log, the degree of microangiopathy as assessed by Nailfold Capillary Microscopy (NCM), the number of incident digital ulcers (DU) and the Scleroderma Health Assessment Questionnaire (SHAQ).