Nodular Shrinking in Dupuytren Disease
- Conditions
- Dupuytren's Disease
- Interventions
- Drug: Vitamin E-creme (Remederm®) vs Vaseline (Placebo)Procedure: Ultrasound measurement
- Registration Number
- NCT06321991
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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.
- Detailed Description
Dupuytren disease (DD) is a common hand disorder with disabling finger contractures that may require surgery to restore function. The contractures are caused by progressive fibroproliferative tissue forming nodules and strands in the palmar fascia that eventually cause loss of finger extension. In the early stages of the disease, the nodules (Tubiana stage 0) are usually painless, but a reason for concern to many patients. They often seek the hand surgeon's advice and worry about losing hand function the coming years, commonly requesting for precautionary measures to stop evolution towards contractures (Tubiana stage 1-4). 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.
However, this is needed to explore any efficient preventive treatment that may be cost-efficient for patients and healthcare.
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. Therefore, it is recommended to consider local creams to the palms in such situation.
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. In clinical practice, although clinical staging of contractures is reliable, stage 0 (nodules) is more challenging to quantify. If observed, nodules (evolution) are often measured by clinical yardstick assessment. However, this technique is unvalidated and unreliable with inevitable significant inter- and intra-observer unreliability, which may improve with sonography. 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. The V-Scan (simple office-based Bluetooth ultrasonography) may aid to achieve this and its use is successfully implemented since 1 year at the hand Surgery department at Université Catholique de Louvain (UCL) by and under supervision of Prof Dr X. Libouton.
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.
Rationale: Application of antioxidant creme cause V-scan measurable arrest or even shrinking of the nodules in stage 0 of DD.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dupuytren Disease patients receiving Remederm® (Vitamine E creme) Vitamin E-creme (Remederm®) vs Vaseline (Placebo) 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) Dupuytren Disease patients receiving Vasiline (Placebo) Vitamin E-creme (Remederm®) vs Vaseline (Placebo) 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 Dupuytren Disease patients receiving Vasiline (Placebo) Ultrasound measurement 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 Dupuytren Disease patients receiving Remederm® (Vitamine E creme) Ultrasound measurement 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)
- Primary Outcome Measures
Name Time Method Downsizing of the largest nodule diameter 1 year A significant downsize (\>1mm because V-scan (ultrasonography) is accurate to 1mm) of the largest nodule diameter in the palm of the hand.
- Secondary Outcome Measures
Name Time Method Recurrence rate 1 year Recurrence is defined as the clinical re-appearance of the treated nodules or a significant increase of diameter (\>1mm) or evolution to a higher stage (Tubiana stage 1-4) of the disease than 0 at intake.
VAS questionnaire on pain 1 year The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The patient is asked to rate their current level of pain by placing a mark on the line.
VAS questionnaire on satisfaction 1 year The Visual Analogue Scale (VAS) measures satisfaction. The VAS consists of a 10cm line, with two end points representing 0 ('complete dissatisfaction') and 10 ('full satisfaction'). The patient is asked to rate their current level of satisfaction by placing a mark on the line.
QUICK Dash for functionality 1 year This questionnaire asks the patient about the symptoms as well as the ability to perform certain activities. It consists of 11 items ranging from 1 ('not at all/no difficulty') to 5 ('extremely/unable').
Range of motion 1 year By using goniometry of Distal interphalangeal, Proximal Interphalangeal and metacarpophalangeal joints
Abe Diathesis scoring Baseline An objective method to evaluate the risk of recurrence and extension of Dupuytren's disease. This scoring counts 1 point for each for bilateral, small finger surgery and if onset \< 50 y. The scoring counts 2 points each for Ledderhose, knuckle pads, thumb / index disease. Diathesis score = sum of points. Increased risk for score \> 4.
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium