Nodular Shrinking in Dupuytren Disease

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Dupuytren's Disease

In brief

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.

Key facts

Study ID: NCT06321991
Run by: Universitaire Ziekenhuizen KU Leuven
People needed: 80
Starts: 2024-02-15
Expected to finish: 2027-03-01
Last updated by the study team: 2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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.

Where it is running

UZ Leuven — Leuven, Vlaams-Brabant, Belgium (enrolling)

Full record on ClinicalTrials.gov

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