Evaluating ultrasound for diagnosing Dupuytren's disease
Ultrasound Features of Dupuytren's Disease: Echogenicity, Skin Involvement and Microvascularisation
This study is testing if ultrasound can help doctors better diagnose Dupuytren's disease in patients by providing more detailed information about their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06956027 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of ultrasound as a diagnostic tool for Dupuytren's disease (DD), a condition that affects hand function. Currently, diagnosis relies heavily on clinical evaluations and range of motion measurements, which may not provide comprehensive insights. The study aims to assess various ultrasound parameters that could serve as prognostic biomarkers for DD. By exploring this non-invasive and radiation-free method, the research seeks to enhance evidence-based decision-making in treatment options for patients with DD.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Dupuytren's disease at an early stage, specifically those with soft nodules and self-reported rapid progression.
Not a fit: Patients with advanced Dupuytren's disease or those with firm, fibrotic nodules may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and treatment options for patients with Dupuytren's disease.
How similar studies have performed: While the use of ultrasound in Dupuytren's disease is not standard care, similar studies in other conditions have shown promise in utilizing ultrasound for diagnostic purposes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven, Vlaams-Brabant
- Universitaire Ziekenhuizen KU Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Ilse Degreef, Prof. Dr. — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Ilse Degreef, Prof. Dr.
- Email: ilse.degreef@uzleuven.be
- Phone: +32 16 33 88 43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.