Nodular Shrinking in Dupuytren Disease
ConditionDupuytren's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Vitamin E-creme (Remederm®) vs Vaseline (Placebo)
DrugLouis 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®.
Ultrasound measurement
Procedure/SurgeryNodule evolution will be measured with ultrasound.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Dupuytren Disease patients receiving Vasiline (Placebo)Placebo comparator 2 interventions
Group B: Dupuytren Disease patients receiving Remederm® (Vitamine E creme)Active comparator 2 interventions
Trial outcomes
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.
Time frame
1 yearSecondary outcomes
1
VAS questionnaire on pain
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.
Time frame
1 year2
VAS questionnaire on satisfaction
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.
Time frame
1 year3
QUICK Dash for functionality
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').
Time frame
1 year4
Abe Diathesis scoring
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.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov