An observational study in Dupuytren Contracture and Disease Progression, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by University Medical Center Groningen · Observational
Dupuytren disease (DD) is a progressive fibromatosis of the palmar fascias of the hand and fingers, which may lead to extension deficits of the fingers. The disease can be very disabling in moderate and severe cases, whereby performing normal daily activities can become very problematic. The aetiology and pathogenesis are not completely understood. There is a genetic disposition and it is influenced by environmental factors. The disease is especially prevalent in white males of Northern European descent above 50 years of age. There is paucity of knowledge about the natural progression of the disease. Several studies have been conducted on progression of disease and from these studies it becomes obvious that the disease is progressive over several years. However, in most studies only one moment of follow-up has taken place, so the course of the progression over time is unknown.
The aim of this study is to enhance our knowledge on the natural disease progression of DD at different stages.
Objective:
Secondary objectives:
f. To determine whether the echogenicity of the nodules can predict progression g. To determine whether extension deficit measurements can be replaced by measurements of extension, and whether this will facilitate the statistical analysis h. To determine the association between passive and active measurements of extension and extension deficit, and to see whether active measurements can be derived from passive measurements and vice versa.
Secondary study parameters:
78 studies on the registry are indexed under Dupuytren Contracture; 18 are open to participants now.
This study's enrollment of 261 is above the median of 80 across 19 observational studies indexed under Dupuytren Contracture.
Browse Dupuytren Contracture studies →University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 176 are open to participants now.
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Patients with Dupuytren Disease who participated in prior studies and patients from the outpatient clinic
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Exclusion Criteria:
The course of DD: passive and active extension deficit and dimension of palpable nodules and cords
Active and passive extension deficit is measured with a goniometer at joint level Dimension of nodules and cords is measured using a tumorimeter
Time frame: every 6-12 months
Disease activity: Echogenicity and nodule hardness
Activity of a nodule is determined by 1) echogenicity of the ultrasound image in sagittal and transversal plane, 2) hardness of the nodule determined by tonometry
Time frame: every 12 months, starting from 2016 (ultrasound) and 2018 (tonometry)
Patient-reported hand function: MHQ, PRWHE and URAM
To study what problems patients with DD experience in daily life, PROMs are used. MHQ and PRWHE in the first 2 years, URAM later on
Time frame: every 6-12 months
Plan to share: No — There is no plan available, but we are open for collaboration
No publications or documents are linked to this record.
Ran from Jun 2012 to primary completion in Mar 2023, 129 months.
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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