NCT07306884

Neurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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, and sonographic techniques offers the potential for earlier detection, improved diagnostic accuracy, and optimized patient management.

Conditions

• Diabete Mellitus
• Peripheral (Sensorimotor) Diabetic Polyneuropathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-01-01
• Completion: 2027-02-01
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

1 site across 1 country: Egypt