Nodular Shrinking in Dupuytren Disease

Официальное название

Nodular Shrinking in Stage 0 Dupuytren Disease: an Evidence-based Approach for Early Stage Treatment to Prevent Progression to Advanced Finger Contractures

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Vitamin E-creme (Remederm®) vs Vaseline (Placebo)
  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®.
• Процедура Ultrasound measurement
  Nodule evolution will be measured with ultrasound.

Первичные конечные точки

• Downsizing of the largest nodule diameter [Срок оценки: 1 year]

Вторичные конечные точки (6)

• VAS questionnaire on pain [Срок оценки: 1 year]
• VAS questionnaire on satisfaction [Срок оценки: 1 year]
• QUICK Dash for functionality [Срок оценки: 1 year]
• Abe Diathesis scoring [Срок оценки: Baseline]
• Range of motion [Срок оценки: 1 year]
• Recurrence rate [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• UZ Leuven — Leuven

Идентификаторы

NCT: NCT06321991 · S68382

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗