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NCT Number: NCT06133244

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

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.

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years

Exclusion criteria

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

Treatment and study plan

Imaging, blood samples, fuctional tests and physical examination

Diagnostic Test

Imaging, blood samples, fuctional tests and physical examination

Primary outcomes

  1. 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

    Time frame: 2 years

Secondary outcomes

  1. Identify underlying mechanisms

    Time frame: 2 years

  2. - Validation of the Dutch PASTUL questionnaire

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Leiden University Medical Center
  • Radboud University Medical Center
  • Royal Free Hospital NHS Foundation Trust
  • University Medical Center Groningen

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 15, 2023
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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