Neurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Sensitivity of nerve conduction studies for diagnosing diabetic peripheral neuropathy
研究概览
简要总结
Diabetic peripheral neuropathy causes pain, sensory loss, and foot risk; multimodal assessment enables earlier diagnosis and improved patient management.
详细描述
Diabetic peripheral neuropathy (DPN) is a prevalent and disabling complication of diabetes, associated with pain, sensory deficits, gait instability, and increased risk of foot ulcers and amputation. Conventional diagnostic methods, such as nerve conduction studies, primarily identify established disease and may overlook early or autonomic involvement. A multimodal assessment integrating neurophysiological, autonomic, and sonographic techniques offers the potential for earlier detection, improved diagnostic accuracy, and optimized patient management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-75 years with type 1 or type 2 diabetes (with or without diabetic peripheral neuropathy), and age and sex-matched healthy controls
排除标准
- •Other causes of neuropathy (e.g., CIDP, trauma, toxins, vitamin deficiencies), advanced renal failure,thyroid disease,chronic alcohol use, pregnancy,
- •presence of implanted cardiac devicesthat may interfere with autonomic testing
结局指标
主要结局
Sensitivity of nerve conduction studies for diagnosing diabetic peripheral neuropathy
时间窗: Baseline (single study visit)
Percentage of participants with clinically diagnosed diabetic peripheral neuropathy who have abnormal nerve conduction study results (reduced amplitude and/or reduced conduction velocity) at the baseline visit.
次要结局
- Correlation between tibial nerve cross-sectional area and tibial motor conduction velocity(Baseline (single study visit))
研究者
Dalia Rageh Daifallah Galal
Resident at Neurology and Psychiatry Department, Assiut University
Assiut University