Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06321991

Nodular Shrinking in Dupuytren Disease

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-11

80

Participants Needed

1

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Nodular Shrinking in Dupuytren Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant or legal representative signed informed consent before assessment
  • Adults aged 18 years or older with primary Dupuytren disease
  • Presence of stage 0 Dupuytren disease nodules at least 5 mm in size on the involved hand without contracture
  • Nodules clearly visible and well distinguished on ultrasound
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years
  • Participation in another interventional trial with an investigational drug
  • Cognitive impairments, severe rheumatic disease, or neurological disorders causing finger flexion deformities
  • Prior Dupuytren surgery on the involved hand
  • Tubiana stage higher than nodular stage 0
  • Open wound on the palm of the treated hand

AI-Screening

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Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

Actively Recruiting

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Research Team

I

Ilse Degreef, Prof. Dr.

CONTACT

A

Anna Tarasiuk

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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