NL-OMON50442招募中3 期
A randomised multicentre, prospective, double blind phase III trial investigating the effect of radiotherapy on patients with Ledderhose disease. - LedRad study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •Before patient randomisation, written informed consent must be given
- •according to ICH/GCP, and local regulations
- •Able and willing to complete quality of life questionnaires in English or
- •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
研究者
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