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Assiut UniversityNeurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy 75
Clinical Trial NCT07306884 is an interventional study for Diabete Mellitus, Peripheral (Sensorimotor) Diabetic Polyneuropathy and is currently not yet recruiting. Enrollment is planned to begin on 1 January 2026 and continue until the study accrues 75 participants. Led by Assiut University, this study is expected to complete by 1 February 2027. The latest data from ClinicalTrials.gov was last updated on 29 December 2025.
Brief Summary
Diabetic peripheral neuropathy causes pain, sensory loss, and foot risk; multimodal assessment enables earlier diagnosis and improved patient management.
Detailed Description
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...Show More
Official Title
Neurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy
Conditions
Diabete MellitusPeripheral (Sensorimotor) Diabetic PolyneuropathyOther Study IDs
- 09-2025-200567
NCT ID Number
Start Date (Actual)
2026-01
Last Update Posted
2025-12-29
Completion Date (Estimated)
2027-02
Enrollment (Estimated)
75
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Diabete Mellitus
Peripheral neuropathy
Neurophysiological studies
Nerve ultrasound
automatic assessment
Peripheral neuropathy
Neurophysiological studies
Nerve ultrasound
automatic assessment
Primary Purpose
Screening
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OtherDiabetic patients with symptomatic peripheral neuropathy. | Nerve conduction study 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. |
OtherDiabetic without any clinical features nor complaints of peripheral neuropathy | Nerve conduction study 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 |
OtherHealthy individuals. | Nerve conduction study 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 |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
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
Assiut University1409 active studies to exploreStudy Responsible Party
Dalia Rageh Daifallah Galal, Principal Investigator, Resident at Neurology and Psychiatry Department, Assiut University
Study Central Contact
Contact: Dalia Galal, +201090463145, [email protected]
1 Study Locations in 1 Countries
Asyut Governorate
Department of Neurology, Faculty of Medicine,Assiut university, Asyut, Asyut Governorate, 71511, Egypt
Ahmed Hamed, Contact, +201011144391, [email protected]