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Status:

RECRUITING

Ultrasound Features of Dupuytren's Disease

Lead Sponsor:

Universitaire Ziekenhuizen KU Leuven

Conditions:

Dupuytren's Disease

Eligibility:

All Genders

Phase:

NA

Brief Summary

Dupuytren's disease (DD) is a benign and progressive condition that affects the palmar aponeurosis with a very high global incidence. It can result in significant loss of hand function or can inhibit ...

Detailed Description

Dupuytren's disease (DD) is a benign and progressive condition that affects the palmar aponeurosis with a very high global incidence. It can result in significant loss of hand function or can inhibit ...

Eligibility Criteria

Inclusion

  • Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  • 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.
  • 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.
  • 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.
  • Participant agrees to not undergo any form of surgical treatment for DD during the duration of their participation, being 6 months.
  • Participant agrees to return to the clinic after 6 months voluntarily for follow-up measurements.

Exclusion

  • 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.
  • Participant has received prior treatment for Dupuytren's disease (needle fasciotomy, (micro)fasciectomy) in the hand under investigation.
  • Participant's affected finger exceeds a TPED over 90° (= Tubiana stage III) (this will affect the value of any US images taken)
  • Participant undergoes treatment for DD during the course of their participation in this study: exhaustive list: fasciectomy/fasciotomy/stretching braces/collagenase injections

Key Trial Info

Start Date :

April 24 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2027

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT06956027

Start Date

April 24 2025

End Date

April 1 2027

Last Update

May 2 2025

Active Locations (1)

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1

Universitaire Ziekenhuizen KU Leuven

Leuven, Vlaams-Brabant, Belgium, 3000