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临床试验/NCT06321991
NCT06321991招募中2 期

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

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年2月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
80
试验地点
2
主要终点
Downsizing of the largest nodule diameter

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

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).

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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
  • Open wound in the palm of the treated hand.

研究组 & 干预措施

Dupuytren Disease patients receiving Vasiline (Placebo)

Placebo Comparator

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

干预措施: Vitamin E-creme (Remederm®) vs Vaseline (Placebo) (Drug)

Dupuytren Disease patients receiving Vasiline (Placebo)

Placebo Comparator

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

干预措施: Ultrasound measurement (Procedure)

Dupuytren Disease patients receiving Remederm® (Vitamine E creme)

Active Comparator

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)

干预措施: Vitamin E-creme (Remederm®) vs Vaseline (Placebo) (Drug)

Dupuytren Disease patients receiving Remederm® (Vitamine E creme)

Active Comparator

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)

干预措施: Ultrasound measurement (Procedure)

结局指标

主要结局

Downsizing of the largest nodule diameter

时间窗: 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.

次要结局

  • Recurrence rate(1 year)
  • VAS questionnaire on pain(1 year)
  • VAS questionnaire on satisfaction(1 year)
  • QUICK Dash for functionality(1 year)
  • Range of motion(1 year)
  • Abe Diathesis scoring(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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