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Nodular Shrinking in Dupuytren Disease

Study acronym: Echo
StatusRecruiting
PhasePhase 2
Started2024-02-15
View on ClinicalTrials.gov ↗

Amendment history

2026-05-05
minor
Study Status, Oversight v3
Primary completion date2026-03-01→2027-03-01
Completion date2026-03-01→2027-03-01
2025-04-10
minor
Study Status, Oversight v2
Re-verified, no change to tracked fields
2024-03-20
minor
Study Status, Outcome Measures v1
Primary endpoints1 entry, revised
ReductionDownsizing of the largest nodule diameter
2024-03-19
minor
Original filing
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.
Trial Details
NCT Number NCT06321991
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Conditions Dupuytren's Disease
Enrollment 80 participants
Start Date 2024-02-15
Primary Completion 2027-03-01 (estimated)
Study Completion 2027-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-11