protocolSection identificationModule nctId: NCT06321991, orgStudyIdInfo id: S68382, briefTitle: Nodular Shrinking in Dupuytren Disease, acronym: Echo, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Dupuytren's Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: 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)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Vitamin E-creme (Remederm®) vs Vaseline (Placebo), interventions name: Ultrasound measurement, outcomesModule primaryOutcomes measure: Downsizing of the largest nodule diameter, secondaryOutcomes measure: VAS questionnaire on pain, secondaryOutcomes measure: VAS questionnaire on satisfaction, secondaryOutcomes measure: QUICK Dash for functionality, secondaryOutcomes measure: Abe Diathesis scoring, secondaryOutcomes measure: Range of motion, secondaryOutcomes measure: Recurrence rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Leuven, status: RECRUITING, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, contacts name: Ilse Degreef, Prof. Dr., role: CONTACT, phone: +3216338843, email: ilse.degreef@uzleuven.be, contacts name: Anna Tarasiuk, role: CONTACT, phone: +3216338818, email: orthopedie.research@uzleuven.be, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False