MedPath

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
Read More
Exclusion Criteria
  • Patients with diabetic cheiroarthropathy and Dupuytren's disease, based on expert opinion
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
SSc with hand contracturesImaging, blood samples, fuctional tests and physical examination-
VEDOSSImaging, blood samples, fuctional tests and physical examinationdefined 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 contracturesImaging, blood samples, fuctional tests and physical examination-
Primary Outcome Measures
NameTimeMethod
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-up2 years
Secondary Outcome Measures
NameTimeMethod
Identify underlying mechanisms2 years
- Validation of the Dutch PASTUL questionnaire2 years

Trial Locations

Locations (1)

UMC Utrecht

🇳🇱

Utrecht, Netherlands

© Copyright 2025. All Rights Reserved by MedPath