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临床试验 NCT07306884 针对糖尿病，Peripheral (Sensorimotor) Diabetic Polyneuropathy目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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艾斯尤特大学Neurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy 75
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临床试验NCT07306884是一项针对糖尿病，Peripheral (Sensorimotor) Diabetic Polyneuropathy的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年1月1日开始，预计招募75名患者。该研究由艾斯尤特大学主导，计划于2027年2月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年12月29日。
简要概括
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...显示更多
官方标题
Neurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy
疾病
糖尿病Peripheral (Sensorimotor) Diabetic Polyneuropathy其他研究标识符
- 09-2025-200567
NCT编号
实际开始日期
2026-01
最近更新发布
2025-12-29
预计完成日期
2027-02
计划入组人数
75
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
Diabete Mellitus
Peripheral neuropathy
Neurophysiological studies
Nerve ultrasound
automatic assessment
Peripheral neuropathy
Neurophysiological studies
Nerve ultrasound
automatic assessment
主要目的
筛查
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
其他Diabetic patients with symptomatic peripheral neuropathy. | 神经传导研究 Nerve conduction studies (NCS) are widely regarded as the gold standard for evaluating large-fiber peripheral nerve function. They measure conduction velocity, latency, and amplitude, providing objective evidence of axonal loss or demyelination. While highly specific, NCS often detect abnormalities only in established diabetic peripheral neuropathy, limiting their sensitivity for early or subclinical disease. Nerve ultrasound High-resolution ultrasound (HRUS) is a non-invasive imaging tool that allows structural evaluation of peripheral nerves. It can measure cross-sectional area (CSA), visualize fascicular pattern, and detect nerve enlargement or structural abnormalities. In diabetic peripheral neuropathy, HRUS provides complementary information to functional tests and may identify early or subclinical changes. |
其他Diabetic without any clinical features nor complaints of peripheral neuropathy | 神经传导研究 Nerve conduction studies (NCS) are widely regarded as the gold standard for evaluating large-fiber peripheral nerve function. They measure conduction velocity, latency, and amplitude, providing objective evidence of axonal loss or demyelination. While highly specific, NCS often detect abnormalities only in established diabetic peripheral neuropathy, limiting their sensitivity for early or subclinical disease. Nerve ultrasound High-resolution ultrasound (HRUS) is a non-invasive imaging tool that allows structural evaluation of peripheral nerves. It can measure cross-sectional area (CSA), visualize fascicular pattern, and detect nerve enlargement or structural abnormalities. In diabetic peripheral neuropathy, HRUS provides complementary information to functional tests and may identify early or subclinical changes. Autonomic assessment Autonomic testing provides insight into small-fiber and autonomic nervous system function, often impaired early in diabetic peripheral neuropathy. Heart rate variability (HRV) during deep breathing and postural change is a simple, non-invasive method to detect cardiovascular autonomic dysfunction |
其他Healthy individuals. | 神经传导研究 Nerve conduction studies (NCS) are widely regarded as the gold standard for evaluating large-fiber peripheral nerve function. They measure conduction velocity, latency, and amplitude, providing objective evidence of axonal loss or demyelination. While highly specific, NCS often detect abnormalities only in established diabetic peripheral neuropathy, limiting their sensitivity for early or subclinical disease. Nerve ultrasound High-resolution ultrasound (HRUS) is a non-invasive imaging tool that allows structural evaluation of peripheral nerves. It can measure cross-sectional area (CSA), visualize fascicular pattern, and detect nerve enlargement or structural abnormalities. In diabetic peripheral neuropathy, HRUS provides complementary information to functional tests and may identify early or subclinical changes. Autonomic assessment Autonomic testing provides insight into small-fiber and autonomic nervous system function, often impaired early in diabetic peripheral neuropathy. Heart rate variability (HRV) during deep breathing and postural change is a simple, non-invasive method to detect cardiovascular autonomic dysfunction |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Sensitivity of nerve conduction studies for diagnosing diabetic peripheral neuropathy | 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. | Baseline (single study visit) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Correlation between tibial nerve cross-sectional area and tibial motor conduction velocity | Correlation coefficient between tibial nerve cross-sectional area measured by high-resolution ultrasound and tibial motor nerve conduction velocity at the baseline visit. | Baseline (single study visit) |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
是
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
- 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
艾斯尤特大学1409 个活跃的临床试验可供探索研究责任方
Dalia Rageh Daifallah Galal, 主要研究者, Resident at Neurology and Psychiatry Department, Assiut University
研究中心联系人
联系人: Dalia Galal, +201090463145, [email protected]
1 位于 1 个国家/地区的研究中心
Asyut Governorate
Department of Neurology, Faculty of Medicine,Assiut university, Asyut, Asyut Governorate, 71511, Egypt
Ahmed Hamed, 联系人, +201011144391, [email protected]