NCT06321991 Nodular Shrinking in Dupuytren Disease
| NCT ID | NCT06321991 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Dupuytren's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-02-15 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2024-02-15 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Dupuytren disease (DD) is a common hand disorder with disabling finger contractures that may require surgery to restore function. In the early stages of the disease, the nodules (Tubiana stage 0) are usually painless, but a reason for concern to many patients. Not rarely, lifestyle measures and even risky treatment options as radiotherapy are advised, yet no therapy to prevent disease evolution has a solid proven effect. Furthermore, reliable non-invasive measurement of early stage DD is not validated. Evidence was found that pharmacotherapy may influence DD evolution, but valuable clinical trials are limited. Case series and non-published explorative follow-up suggested local treatment with antioxidant vitamin E to possibly interfere with an evolution of DD nodules to contracting strands. This study aims to provide evidence on efficiency of this non-invasive treatment option. Secure measurement of nodule evolution is a clinical challenge. To measure this evolution, ultrasound and MRI scanning are currently being performed. Stage 0 (nodules) is more challenging to quantify. A strict individual follow-up by the treating clinician is needed to standardize measurement of selected (treated) nodules. Therefore, simple ultrasound by the treating clinician may provide an good tool to collect data. This study aims to introduce and validate this non-invasive scan method and provide a prospective double blind investigation of a measurable effect of non-invasive preventive treatment for stage 0 DD to improve clinical outcome.
Eligibility Criteria
Inclusion Criteria: * The participant or his/her legally authorized representative voluntary signed the informed consent prior to the first assessment. * Participants are ≥ 18 years and diagnosed with primary Dupuytren disease. * Included patients have a stage 0 DD (nodule of at least 5 mm in the involved hand without contracture). * The participant has well distinguished noduli that are clearly visible on US (ultrasound) Exclusion Criteria: * Patients \< 18 years. * Patient included in an interventional trial with an investigational medicinal product. * Patients with cognitive impairments, severe rheumatic disease and neurological disorders leading to flexion deformities of the fingers. * Patients with prior Dupuytren surgery in the involved hand. * Patients with a higher Tubiana grading than nodular stage 0. * Open wound in the palm of the treated hand.
Contact & Investigator
Ilse Degreef, Prof. Dr.
PRINCIPAL INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Frequently Asked Questions
Who can join the NCT06321991 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dupuytren's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06321991 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06321991 currently recruiting?
Yes, NCT06321991 is actively recruiting participants. Contact the research team at ilse.degreef@uzleuven.be for enrollment information.
Where is the NCT06321991 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT06321991 clinical trial?
NCT06321991 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Ilse Degreef, Prof. Dr. at Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 80 participants.