Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME)
Recruiting
- Conditions
- Systemic Sclerosis
- Interventions
- Diagnostic Test: Imaging, blood samples, fuctional tests and physical examination
- Registration Number
- NCT06133244
- Lead Sponsor
- UMC Utrecht
- Brief Summary
Almost 90% of systemic sclerosis (SSc) patients experience hand function limitation, which leads to impaired daily functioning and work participation. An important cause of impaired hand function are contractures of the hand, which are reported in up to a half of patients. With this longitudinal cohort study in patients with SSc and VEDOSS (very early diagnosis of systemic sclerosis) the investigators aim to gain more insight into processes involved in hand function impairment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- Age > 18 years
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Exclusion Criteria
- Patients with diabetic cheiroarthropathy and Dupuytren's disease, based on expert opinion
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SSc with hand contractures Imaging, blood samples, fuctional tests and physical examination - VEDOSS Imaging, blood samples, fuctional tests and physical examination defined as RP, presence of SSc specific autoantibodies (ACA, ATA, ARA), puffy fingers and abnormal nailfold capillaroscopy (giant capillaries or capillary loss with or without haemorrhages), but not fulfilling the EULAR-ACR 2013 classification criteria for SSc SSc with disease duration of < 4 years without hand contractures Imaging, blood samples, fuctional tests and physical examination -
- Primary Outcome Measures
Name Time Method Determination of risk factors for hand function impairment in systemic sclerosis (SSc) patients with early disease, very early disease and established hand impairment (contractures) at 2 years follow-up 2 years
- Secondary Outcome Measures
Name Time Method Identify underlying mechanisms 2 years - Validation of the Dutch PASTUL questionnaire 2 years
Trial Locations
- Locations (1)
UMC Utrecht
🇳🇱Utrecht, Netherlands