Treatment for early Dupuytren's disease using vitamin E cream
Nodular Shrinking in Stage 0 Dupuytren Disease: an Evidence-based Approach for Early Stage Treatment to Prevent Progression to Advanced Finger Contractures
This study is testing if using vitamin E cream can help people with early Dupuytren's disease stop their fingers from getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06321991 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of vitamin E cream in preventing the progression of Dupuytren's disease, a condition that causes painful finger contractures. Participants with early-stage Dupuytren's disease will be treated with either vitamin E cream or a placebo, and their condition will be monitored using ultrasound measurements. The goal is to provide evidence for a non-invasive treatment option that could help manage this common hand disorder. The study aims to address the lack of validated non-invasive measurement techniques and effective preventive treatments for Dupuytren's disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with primary Dupuytren's disease at stage 0.
Not a fit: Patients with advanced stages of Dupuytren's disease or those who have had prior surgery on the affected hand may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could help prevent the progression of Dupuytren's disease, reducing the need for surgical interventions.
How similar studies have performed: While there is limited evidence from previous studies regarding pharmacotherapy for Dupuytren's disease, this specific approach using vitamin E cream is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 this trial is running
Leuven, Vlaams-Brabant
- UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Ilse Degreef, Prof. Dr. — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Ilse Degreef, Prof. Dr.
- Email: ilse.degreef@uzleuven.be
- Phone: +3216338843
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.