NCT03507010进行中（未招募）3 期
Ledderhose Disease: Radiotherapy or Not? A Randomised, Multicentre, Prospective, Double Blind Phase III Trial Investigating the Effect of Radiotherapy on Patients With Ledderhose Disease
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale
研究概览
简要总结
The aim of the LedRad trial is to determine the efficacy and durability of radiotherapy as treatment for patients with Ledderhose disease and to compare this to the natural course of Ledderhose disease.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with painful Ledderhose disease. The pain score measured with the VAS score and is at least 2 on the 11-point scale (0 = no pain to 10 = worst imaginable pain).
- •Age ≥ 18 years
- •WHO performance status 0, 1 or 2 (Appendix, section 18)
- •Before patient randomisation, written informed consent must be given according to ICH/GCP, and WMO requirements.
- •Controlling the Dutch language (speaking and reading).
- •Able and willing to complete quality of life questionnaires in Dutch
- •Must be accessible for treatment follow-up
排除标准
- •Surgical intervention before for Ledderhose disease
- •Previous radiation treatment for Ledderhose disease
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Not able to lay prone for at least fifteen minutes
- •Females who are pregnant at entry or who want to become pregnant within six months.
研究组 & 干预措施
Radiotherapy
Experimental
Patients assigned to the Radiotherapy group are treated with electrons and will receive a total dose of 30 Gy.
干预措施: Radiotherapy (Radiation)
Sham Radiotherapy
Placebo Comparator
Patients assigned to the sham-radiotherapy group will not actually receive radiation. For these patients the radiation is simulated.
干预措施: Sham Radiotherapy (Other)
结局指标
主要结局
Numeric Rating Scale
时间窗: 12 months
Determine pain with the Numeric Rating Scale
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(18 months)
- Numeric Rating Scale(6 and 18 months)
- Walking distance(6, 12 and 18 months)
- Quality of life (1)(6, 12 and 18 months)
- Quality of life (2)(6, 12 and 18 months)
- Walking motion(12 months)
- Quality of life (3)(6, 12 and 18 months)
- Size of ledderhose nodules(12 months)
- Cost-effectiveness analysis (CEA)(6, 12 and 18 months)
研究者
研究点 (1)
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