Neurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy

Assiut University

Status: Not yet enrolling

Conditions: Diabete Mellitus; Peripheral (Sensorimotor) Diabetic Polyneuropathy

Treatments: Diagnostic Test: Autonomic assessment; Diagnostic Test: Nerve ultrasound; Diagnostic Test: Nerve conduction study

Study type: Interventional

Funder types: Other

Identifiers

NCT07306884

09-2025-200567

Details and patient eligibility

About

Diabetic peripheral neuropathy causes pain, sensory loss, and foot risk; multimodal assessment enables earlier diagnosis and improved patient management.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Diabetic patients with symptomatic peripheral neuropathy.

Other group

Treatment:

Diagnostic Test: Nerve conduction study

Diagnostic Test: Nerve ultrasound

Diabetic without any clinical features nor complaints of peripheral neuropathy

Other group

Treatment:

Diagnostic Test: Nerve conduction study

Diagnostic Test: Nerve ultrasound

Diagnostic Test: Autonomic assessment

Healthy individuals.

Other group

Treatment:

Diagnostic Test: Nerve conduction study

Diagnostic Test: Nerve ultrasound

Diagnostic Test: Autonomic assessment