Department of Neurology, Faculty of Medicine,Assiut university
Asyut, Asyut Governorate, 71511, Egypt
NCT Number: NCT07306884
Diabetic peripheral neuropathy causes pain, sensory loss, and foot risk; multimodal assessment enables earlier diagnosis and improved patient management.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Asyut, Asyut Governorate, 71511, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
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.
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 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
Time frame: Baseline (single study visit)
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.
Time frame: Baseline (single study visit)
Correlation coefficient between tibial nerve cross-sectional area measured by high-resolution ultrasound and tibial motor nerve conduction velocity at the baseline visit.
Contact information is provided by the study sponsor or research team.
Assiut University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07172763
Diabete Mellitus, Diabetes Mellitus
View Trial DetailsNCT07141992
Diabete Mellitus, Diabetes Complications
Karachi, Sindh, Pakistan
View Trial DetailsNCT07706088
Diabete Mellitus, Diabetes Mellitus
View Trial DetailsNCT07676214
Body Weight, Cardiovascular Diseases
View Trial Details