Raynauds phenomenon scleroderma
Conditions
Interventions
The study will be a double-blinded study on 100 adult patients with systemic
sclerosis. All patients will wear both normal gloves and gloves containing
silver fibres, each during a period of 6 weeks
group II: starting with orange gloves without silver
fibers, followed by green gloves with silver fibers
group 3: starting with
green gloves with silver fibers, followed by orange gloves without silver
fibers
group 4: starting with green gloves without silver fibers, followed by
orange gloves with silver fibers.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion 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
Exclusion criteria: - Past history of sympathectomy for Raynaud*s phenomenon - Current treatment with iloprost, or iloprost infusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of this study are the Raynaud Condition Score and the VAS for burden caused by Raynaud*s. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Netherlands
Outcome results
None listed