NCT01498211已完成不适用
Establishement of Normative Intra-epidermal Nerve Fiber Density Using Skin
University Hospital, Strasbourg, France6 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Measure density of intraepidermic nervous fibres by optical and electronic microscopy in a population of healthy witnesses according to the age and the sex.
研究概览
简要总结
Intra-epidermal nerve fiber density can be assessed using skin biopsy. A decrease of this density is used to diagnose small fiber neuropathy, despite the absence of normative data in a selected normal population. To establish a normative set of data matched for age and sex is absolutely needed to evaluate the sensibility and specificity of this test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Man or woman between 20-80 years old
- •Normal subjects without pain and neurological impairment
- •No history of neurological disorder
- •Normal neurological examination
- •Normal ECG
- •Normal clotting sample from less than 6 months
- •Available by phone
排除标准
- •History of alcoholic intoxication or chemotherapy
- •History of diabetes, kidney insufficiency, monoclonal gammapathy, B/C hepatitis, HIV, coeliac disease, sicca syndrome, raynaud syndrome, systemic erythematous lupus, Fabry disease, amylosis, vascularitis
- •Contraindication to xylocaïn with adrenalin
- •At the site of biopsy : surgery, skin pathology, infection, vascular insufficiency
- •Innate or acquired immunosuppression
- •Innate or acquired clotting abnormality
研究组 & 干预措施
Biopsy
Experimental
干预措施: Biopsy (Procedure)
结局指标
主要结局
Measure density of intraepidermic nervous fibres by optical and electronic microscopy in a population of healthy witnesses according to the age and the sex.
时间窗: 1 month
次要结局
未报告次要终点
研究者
研究点 (6)
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