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Clinical Trials/NL-OMON20637
NL-OMON20637
Not Yet Recruiting
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

eiden University Medical Center, Haga hospital The Hague, Maasstad Rotterdam.0 sites80 target enrollmentTBD
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Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
eiden University Medical Center, Haga hospital The Hague, Maasstad Rotterdam.
Enrollment
80
Status
Not Yet Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

.A.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
eiden University Medical Center, Haga hospital The Hague, Maasstad Rotterdam.

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

Outcomes

Primary Outcomes

Not specified

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