Ultrasound Features of Dupuytren's Disease

NCT06956027 | Recruiting

• 1 other identifier: S70180
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Dupuytren Disease

Outcome Measures

Primary Outcomes (5)

• Echogenicity

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

  At screening and at 6 month follow-up visit

• Distance from the Duputren's Disease lesion to the skin

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

  At screening and at 6 month follow-up visit

• Microvascularisation

  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)

  At screening and at 6 month follow-up visit

• Disease progression determined by TPED increase after 6 months

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

  At screening and at 6 month follow-up visit

• Disease progression determined by URAM increase after 6 months

  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)

  At screening and at 6 month follow-up visit

Secondary Outcomes (2)

• Diathesis score

  At screening and at 6 month follow-up visit

• Incidence of the presence of microvascularisation

  At screening and at 6 month follow-up visit

Study Arms (1)

Patients with Dupuytren disease

OTHER

Population of Dupuytren's Disease patients who fulfill study criteria

Diagnostic Test: Ultrasound assesment; Procedure: ROM measurement

Interventions

ROM measurement PROCEDURE

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

Patients with Dupuytren disease

Ultrasound assesment DIAGNOSTIC_TEST

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

Patients with Dupuytren disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Universitaire Ziekenhuizen KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ilse Degreef, Prof. Dr.

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilse Degreef, Prof. Dr.

CONTACT

+32 16 33 88 43; ilse.degreef@uzleuven.be

Anna Tarasiuk

CONTACT

+32 16 33 88 18; orthopedie.research@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 2, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)