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Search / Trial NCT06956027

Ultrasound Features of Dupuytren's Disease

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Apr 24, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying Dupuytren's disease (DD), a condition that causes thickening and shortening of the tissue in the palm of the hand, which can limit hand function and make daily activities difficult. Researchers want to explore the use of ultrasound (US) as a new, non-invasive way to diagnose and monitor DD. Currently, doctors primarily rely on physical examinations and patient reports to decide on treatment, but this study aims to gather more scientific data to improve how we understand and treat this condition.

To participate in the trial, individuals need to be diagnosed with early-stage Dupuytren's disease and have soft nodules in their hands. They should not have had any previous treatments for DD and must agree not to undergo surgery during the six-month study period. Participants will return to the clinic after six months for follow-up measurements. The trial is open to all genders and ages, and those interested should be ready to provide consent and share their experiences with the condition. This research could help pave the way for better diagnostic tools and treatment options for people living with Dupuytren's disease.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  • 2. Clinical diagnosis of DD and a Tubiana staging not exceeding stage II, TPED does not exceed 90°; this is chosen because to great of a contracture will pose problems with taking the US measurement.
  • 3. In the clinical assessment the subject has rather soft DD nodules, more firm nodules are more fibrotic and are less likely to contain blood vessels. This will be confirmed by a hand surgeon at the screening phase.
  • 4. Participant has self reported rapid progression. In the anamnesis the subject reports one of the following: The DD lesion has changed in degree of contracture/nodule size recently; the patient is worried about the function of the involved fingers/hand due to recent progression; the patient is new to DD or has just started experiencing greater discomfort due to a previous existing nodule.
  • 5. Participant agrees to not undergo any form of surgical treatment for DD during the duration of their participation, being 6 months.
  • 6. Participant agrees to return to the clinic after 6 months voluntarily for follow-up measurements.
  • Exclusion Criteria:
  • 1. Participant has any other disorder or pathology of the hand/fingers that could affect the quality of US measurements. This list is exhaustive: trigger finger, fracture, hematoma, tenosynovitis, tendon ruptures, scleroderma, fibromatosis, inflammatory conditions, rheumatoid arthritis, osteoarthritis.
  • 2. Participant has received prior treatment for Dupuytren's disease (needle fasciotomy, (micro)fasciectomy) in the hand under investigation.
  • 3. Participant's affected finger exceeds a TPED over 90° (= Tubiana stage III) (this will affect the value of any US images taken)
  • 4. Participant undergoes treatment for DD during the course of their participation in this study: exhaustive list: fasciectomy/fasciotomy/stretching braces/collagenase injections

About Universitaire Ziekenhuizen Ku Leuven

Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.

Locations

Leuven, Vlaams Brabant, Belgium

Patients applied

0 patients applied

Trial Officials

Ilse Degreef, Prof. Dr.

Principal Investigator

Universitaire Ziekenhuizen KU Leuven

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported