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RECRUITING
NCT06321991
PHASE2

Nodular Shrinking in Dupuytren Disease

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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.

Official title: Nodular Shrinking in Stage 0 Dupuytren Disease: an Evidence-based Approach for Early Stage Treatment to Prevent Progression to Advanced Finger Contractures

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-02-15

Completion Date

2026-03-01

Last Updated

2025-04-15

Healthy Volunteers

No

Interventions

DRUG

Vitamin E-creme (Remederm®) vs Vaseline (Placebo)

Louis Widmer Remederm® Face Cream Without Perfume 50 ml is a skin care product that contains vitamin E as an active ingredient. Before applying Remederm®, the following are advised: On dry clean skin thoroughly before applying Remederm®, apply a layer of cream cutaneous to the hand palm, twice a day: morning and evening, massage cream into skin until absorbed. This procedure is applied by the patient treated with Vaseline or Remederm®.

PROCEDURE

Ultrasound measurement

Nodule evolution will be measured with ultrasound.

Locations (1)

UZ Leuven

Leuven, Vlaams-Brabant, Belgium