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NCT06133244 Clinical Trial

Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME)

Systemic Sclerosis Clinical Trial

Official title:
Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME) Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06133244
Other study ID # NL85445.041.23
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 19, 2024
Est. completion date April 2028

Study information
Verified date May 2024
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date April 2028
Est. primary completion date April 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > 18 years Exclusion Criteria: - Patients with diabetic cheiroarthropathy and Dupuytren's disease, based on expert opinion

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Imaging, blood samples, fuctional tests and physical examination
Imaging, blood samples, fuctional tests and physical examination

Locations
Country Name City State
Netherlands UMC Utrecht Utrecht

Sponsors (5)
Lead Sponsor Collaborator
UMC Utrecht Leiden University Medical Center, Radboud University Medical Center, Royal Free Hospital NHS Foundation Trust, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Identify underlying mechanisms 2 years
Secondary - Validation of the Dutch PASTUL questionnaire 2 years
See also
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