Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06956027

Ultrasound Features of Dupuytren's Disease

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 that can be used 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.

Recruiting

Interested in participating?

Request Info

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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 that can be used 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Ultrasound assesment

Diagnostic Test

Ultrasound image taken using MV-flow technique for measuring the distance skin-lesion and echogenicity measurement

ROM measurement

Procedure

Range Of Motion measurement of affected finger(s) where the ultrasound image will be taken from.

Primary outcomes

  1. Echogenicity

    Time frame: At screening and at 6 month follow-up visit

    A biomarker measured with an ultrasound device that shows high myofibroblast presence (=hypoechogenic) or high collagen in the extracellular matrix (mean gray value).

  2. Distance from the Duputren's Disease lesion to the skin

    Time frame: At screening and at 6 month follow-up visit

    This measurement shows skin involvement in the disease which will influence how it evolves (in millimeters).

  3. Microvascularisation

    Time frame: At screening and at 6 month follow-up visit

    Determine the presence of microvascularisation inside the DD nodule. The presence of this vascularisation could be indicative of faster progression. (Answered with Yes or No)

  4. Disease progression determined by TPED increase after 6 months

    Time frame: At screening and at 6 month follow-up visit

    The Total Passive Extension Deficit (PED) will be measured using a digital goniometer (in degrees). Disease progression when increase is ≥ 5°

  5. Disease progression determined by URAM increase after 6 months

    Time frame: At screening and at 6 month follow-up visit

    The URAM questionnaire is used to determine progression for subject's own experience with the disease. Disease progression if URAM questionnaire score increases with 1 or more points (Minimum score = 0; Maximum score = 45)

Secondary outcomes

  1. Diathesis score

    Time frame: At screening and at 6 month follow-up visit

    This score goes from 0 till 9. To investigate if a high score (≥ 4) correlates with faster disease progression.

  2. Incidence of the presence of microvascularisation

    Time frame: At screening and at 6 month follow-up visit

    The amount of participants with microvascularisation (given in %)

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Tarasiuk

CONTACT

[email protected]

+32 16 33 88 18

Ilse Degreef, Prof. Dr.

CONTACT

[email protected]

+32 16 33 88 43

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Ultrasound Features of Dupuytren's Disease: Echogenicity, Skin Involvement and Microvascularisation

Acronym: Micro in DD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 2, 2025
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.