Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06321991

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

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

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Dupuytren disease (DD) is a common hand condition that causes finger contractures which can limit hand function and may require surgery. Early stage DD involves nodules (Tubiana stage 0) that are usually painless but cause concern for patients worried about disease progression. Current treatments to prevent DD progression lack solid evidence, and non-invasive methods to measure early stage nodules are not yet validated. This research evaluates a non-invasive treatment and aims to improve measurement techniques for early DD nodules. The study compares two groups of patients with stage 0 DD nodules: one receiving a vitamin E cream called Remederm® and the other receiving a placebo cream (Vaseline). The creams are applied twice daily on the palm of the hand. Alongside treatment, ultrasound and MRI scans are used to monitor nodule changes. The study also introduces a simple ultrasound method performed by clinicians to measure nodule size reliably over time. Participants will be followed for one year, during which researchers will track changes in the largest nodule size using ultrasound. They will also assess pain, satisfaction, hand function, range of motion, and recurrence rates through questionnaires and clinical scoring. The study uses a double-blind design to ensure unbiased results. This approach aims to provide evidence on the effectiveness of vitamin E cream as a preventive treatment and validate ultrasound as a measurement tool for early DD nodules.

CONDITIONS

Brief 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 has signed informed consent before first assessment
  • Participants are 18 years or older with primary Dupuytren disease
  • Patients have stage 0 DD with nodules of at least 5 mm on the involved hand without contracture
  • Nodules are clearly visible and well distinguished on ultrasound
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years
  • Participants currently enrolled in another interventional trial with an investigational medicinal product
  • Patients with cognitive impairments, severe rheumatic disease, or neurological disorders causing finger flexion deformities
  • Patients with prior Dupuytren surgery on the involved hand
  • Patients with Tubiana grading higher than stage 0 nodules
  • Patients with open wounds on the palm of the treated hand

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 year

Participants apply either Vitamin E cream or a placebo cream to the palm of the hand twice daily, while ultrasound measurements track nodule size.

Regular visits for ultrasound measurements during the treatment period

Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

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Research Team

I

Ilse Degreef, Prof. Dr.

A

Anna Tarasiuk

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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