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治験 NCT07306884（対象：糖尿病、Peripheral (Sensorimotor) Diabetic Polyneuropathy）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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アシュート大学Neurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy 75
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07306884 は 介入研究 臨床試験 で、糖尿病、Peripheral (Sensorimotor) Diabetic Polyneuropathy に関するものです。現在は 募集準備中 で、2026年1月1日 に開始予定です。75 名の参加者 の募集が計画されています。この試験は アシュート大学 によって主導され、2027年2月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年12月29日 です。
概要
Diabetic peripheral neuropathy causes pain, sensory loss, and foot risk; multimodal assessment enables earlier diagnosis and improved patient management.
詳細説明
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...もっと見る
公式タイトル
Neurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy
疾患名
糖尿病Peripheral (Sensorimotor) Diabetic Polyneuropathyその他の研究識別子
- 09-2025-200567
NCT番号
開始日
2026-01
最終更新日
2025-12-29
終了予定日
2027-02
目標参加者数
75
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集準備中
キーワード
Diabete Mellitus
Peripheral neuropathy
Neurophysiological studies
Nerve ultrasound
automatic assessment
Peripheral neuropathy
Neurophysiological studies
Nerve ultrasound
automatic assessment
主目的
スクリーニング（選別）
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
その他Diabetic patients with symptomatic peripheral neuropathy. | 神経伝導検査 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. |
その他Diabetic without any clinical features nor complaints of peripheral neuropathy | 神経伝導検査 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 |
その他Healthy individuals. | 神経伝導検査 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 |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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) |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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) |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
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
アシュート大学1409 件のアクティブな治験を探索責任者
Dalia Rageh Daifallah Galal, 主任研究者, Resident at Neurology and Psychiatry Department, Assiut University
試験中央連絡先
連絡先: Dalia Galal, +201090463145, [email protected]
1 1カ国の場所
Asyut Governorate
Department of Neurology, Faculty of Medicine,Assiut university, Asyut, Asyut Governorate, 71511, Egypt
Ahmed Hamed, 連絡先, +201011144391, [email protected]