Ultrasound Features of Dupuytren's Disease

Last updated: April 24, 2025
Sponsor: Universitaire Ziekenhuizen KU Leuven
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

ROM measurement

Ultrasound assesment

Clinical Study ID

NCT06956027
S70180
  • All Genders

Study 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 an individual's daily activities or work. Current diagnostics rely on Range Of Motion (ROM) measurements and clinical expertise, where the decision for treatment is primarily based on patient preferences with little scientific research supporting different options in different cases.

With technological advancements new options arise to the possible diagnostic tools we can use for evidence based medicine and shared decision making. One option comes to light for DD because of its cheap, non -invasive and no radiation load, namely ultrasound (US). The use of US for DD is not standard care, due to the lack of research surrounding this tool. This study will provide some insight into the use of US for DD and will primarily try to evaluate different parameters measurable with US that can be used as potential prognostic biomarkers.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Voluntary written informed consent of the participant or their legally authorizedrepresentative has been obtained prior to any screening procedures

  2. Clinical diagnosis of DD and a Tubiana staging not exceeding stage II, TPED does notexceed 90°; this is chosen because to great of a contracture will pose problems withtaking the US measurement.

  3. In the clinical assessment the subject has rather soft DD nodules, more firm nodulesare more fibrotic and are less likely to contain blood vessels. This will beconfirmed by a hand surgeon at the screening phase.

  4. Participant has self reported rapid progression. In the anamnesis the subjectreports one of the following: The DD lesion has changed in degree ofcontracture/nodule size recently; the patient is worried about the function of theinvolved fingers/hand due to recent progression; the patient is new to DD or hasjust started experiencing greater discomfort due to a previous existing nodule.

  5. Participant agrees to not undergo any form of surgical treatment for DD during theduration of their participation, being 6 months.

  6. Participant agrees to return to the clinic after 6 months voluntarily for follow-upmeasurements.

Exclusion

Exclusion Criteria:

  1. Participant has any other disorder or pathology of the hand/fingers that couldaffect 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) (thiswill affect the value of any US images taken)

  4. Participant undergoes treatment for DD during the course of their participation inthis study: exhaustive list: fasciectomy/fasciotomy/stretching braces/collagenaseinjections

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: ROM measurement
Phase:
Study Start date:
April 24, 2025
Estimated Completion Date:
April 01, 2027

Study 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 an individual's daily activities or work. The diagnostic tool that is currently used the most is the clinical evaluation of a hand surgeon, and also the use of a goniometer which measures the total Range of Motion (ROM) a patient still has in his finger, where the decision for treatment is primarily based on patient preferences with little scientific research supporting different options in different cases. Due to a lack of patient satisfaction and high recurrence rates among those who underwent surgery there is a clear need for more knowledge surrounding DD to better understand this disease. This will lead to new possibilities in the field of research and the potential for new treatments.

With technological advancements new options arise to the possible diagnostic tools we can use for evidence based medicine and shared decision making. One option comes to light for DD because of its cheap, non -invasive and no radiation load, namely ultrasound (US). The use of US for DD is not standard care, due to the lack of research surrounding this tool. This study will provide some insight into the use of US for DD and will primarily try to evaluate different parameters measurable with US that can be used as potential prognostic biomarkers. Three different characteristics will be measured: echogenicity, skin involvement, the presence of microvascular structures. In summary, the mentioned parameters could possibly prove to be useful in the assessment of DD patients and could make US a standard in determining disease progression and could make the consideration between different treatment options more evidence based.

Connect with a study center

  • Universitaire Ziekenhuizen KU Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.