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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06133244
Enrollment
300
Registered
2023-11-15
Start date
2024-04-19
Completion date
2028-04-30
Last updated
2024-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

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.

Interventions

DIAGNOSTIC_TESTImaging, blood samples, fuctional tests and physical examination

Imaging, blood samples, fuctional tests and physical examination

Sponsors

University Medical Center Groningen
CollaboratorOTHER
Radboud University Medical Center
CollaboratorOTHER
Leiden University Medical Center
CollaboratorOTHER
Royal Free Hospital NHS Foundation Trust
CollaboratorOTHER
UMC Utrecht
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years

Exclusion criteria

* Patients with diabetic cheiroarthropathy and Dupuytren's disease, based on expert opinion

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Identify underlying mechanisms2 years
- Validation of the Dutch PASTUL questionnaire2 years

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026