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Nodular Shrinking in Dupuytren Disease

RecruitingPhase 2Ages 18 Years - anyAllUniversitaire Ziekenhuizen KU Leuven
NCT06321991 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Dupuytren disease (DD) is a common hand disorder with disabling finger contractures that may require surgery to restore function. In the early stages of the disease, the nodules (Tubiana stage 0) are usually painless, but a reason for concern to many patients. Not rarely, lifestyle measures and even risky treatment options as radiotherapy are advised, yet no therapy to prevent disease evolution has a solid proven effect. Furthermore, reliable non-invasive measurement of early stage DD is not validated. Evidence was found that pharmacotherapy may influence DD evolution, but valuable clinical trials are limited. Case series and non-published explorative follow-up suggested local treatment with antioxidant vitamin E to possibly interfere with an evolution of DD nodules to contracting strands. This study aims to provide evidence on efficiency of this non-invasive treatment option. Secure m

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📋 Eligibility rules (as published)
Inclusion Criteria: * The participant or his/her legally authorized representative voluntary signed the informed consent prior to the first assessment. * Participants are ≥ 18 years and diagnosed with primary Dupuytren disease. * Included patients have a stage 0 DD (nodule of at least 5 mm in the involved hand without contracture). * The participant has well distinguished noduli that are clearly visible on US (ultrasound) Exclusion Criteria: * Patients \< 18 years. * Patient included in an interventional trial with an investigational medicinal product. * Patients with cognitive impairments, severe rheumatic disease and neurological disorders leading to flexion deformities of the fingers. * Patients with prior Dupuytren surgery in the involved hand. * Patients with a higher Tubiana grading than nodular stage 0. * Open wound in the palm of the treated hand.
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What it tests

  • Vitamin E-creme (Remederm®) vs Vaseline (Placebo)
  • Ultrasound measurement
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Where

1 site
UZ Leuven
Leuven, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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