Nodular Shrinking in Dupuytren Disease

NCT06321991 | Recruiting Phase 2

• 1 other identifier: S68382
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dupuytren's Disease

Outcome Measures

Primary Outcomes (1)

• Downsizing of the largest nodule diameter

  A significant downsize (\>1mm because V-scan (ultrasonography) is accurate to 1mm) of the largest nodule diameter in the palm of the hand.

  1 year

Secondary Outcomes (6)

• VAS questionnaire on pain

  1 year

• VAS questionnaire on satisfaction

  1 year

• QUICK Dash for functionality

  1 year

• Abe Diathesis scoring

  Baseline

• Range of motion

  1 year

Study Arms (2)

Dupuytren Disease patients receiving Vasiline (Placebo)

PLACEBO COMPARATOR

40 patients with Dupuytren Disease (primary DD nodules: stage 0, no contracture in the involved hand) will be randomized into the group where they will receive Vasiline

Drug: Vitamin E-creme (Remederm®) vs Vaseline (Placebo); Procedure: Ultrasound measurement

Dupuytren Disease patients receiving Remederm® (Vitamine E creme)

ACTIVE COMPARATOR

40 patients with Dupuytren Disease (primary DD nodules: stage 0, no contracture in the involved hand) will be randomized into the group where they will receive Remederm® (Vitamine E creme)

Drug: Vitamin E-creme (Remederm®) vs Vaseline (Placebo); Procedure: Ultrasound measurement

Interventions

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

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®.

Dupuytren Disease patients receiving Remederm® (Vitamine E creme); Dupuytren Disease patients receiving Vasiline (Placebo)

Ultrasound measurement PROCEDURE

Nodule evolution will be measured with ultrasound.

Dupuytren Disease patients receiving Remederm® (Vitamine E creme); Dupuytren Disease patients receiving Vasiline (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ilse Degreef, Prof. Dr.

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilse Degreef, Prof. Dr.

CONTACT

+3216338843; ilse.degreef@uzleuven.be

Anna Tarasiuk

CONTACT

+3216338818; orthopedie.research@uzleuven.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: To avoid bias, treatment arms will be blinded to Investigators, Trial staff, participants,.. as follows: vitamin E creme will be packaged and labelled in such a way that the visual appearance, nor the smell and/or touch of the creme can be distinguished from placebo (Vaseline).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Simple random allocation will be ensured by the principal investigators' designated staff (study nurse of IORT), who will not be involved in recruiting trial participants, medical care, drug administration or follow-up, through the generation of a random numbers table with computer software program. A randomization list will be prepared by the Sponsor's designated staff, not involved in recruiting Trial participants, medical care, drug administration or follow-up.

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: February 15, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)