Neurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nerve conduction study, Nerve ultrasound, Autonomic assessment.
- Who it may be relevant to
- Registry conditions: Diabete Mellitus, Peripheral (Sensorimotor) Diabetic Polyneuropathy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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, and sonographic techniques offers the potential for earlier detection, improved diagnostic accuracy, and optimized patient management.
Interventions
- Diagnostic test 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. - Diagnostic test 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. - Diagnostic test 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
- Sensitivity of nerve conduction studies for diagnosing diabetic peripheral neuropathy [Time frame: Baseline (single study visit)]
Secondary outcome measures (1)
- Correlation between tibial nerve cross-sectional area and tibial motor conduction velocity [Time frame: Baseline (single study visit)]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Egypt · 1 center
- Department of Neurology, Faculty of Medicine,Assiut university — Asyut
Identifiers
NCT: NCT07306884 · 09-2025-200567