Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Actively Recruiting
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here