NCT05993871View on ClinicalTrials.gov

Diabetic Small Fiber Neuropathy: Clinical, Electrophysiological and Neurosonographic Study

CompletedOBSERVATIONAL
Enrollment

45

Participants

Timeline

Start Date

January 1, 2023

Primary Completion Date

June 30, 2023

Study Completion Date

January 22, 2024

Conditions
Small Fiber NeuropathyDiabetic NeuropathiesAutonomic NeuropathyDiabetic Peripheral NeuropathyPainful Diabetic NeuropathyDiabetic Polyneuropathy
Interventions
DIAGNOSTIC_TEST

Clinical Evaluation/Questionnaires

Anthropometric measures, somatosensory assessment (NPS, UENS, TCNS), autonomic assessment (COMPASS-31, Ewing battery), and severity and quality of life evaluation (NPS, TCNS, COMPASS-31, and EuroQOL-5D-5L index score)

DIAGNOSTIC_TEST

Nerve Conduction Study

Routine Nerve Conduction Study.

DIAGNOSTIC_TEST

Small fiber electrodiagnostic tests

R-R interval analysis, Cutaneous Silent Period and Sympathetic Skin Response.

DIAGNOSTIC_TEST

Nerve Ultrasound

Bilateral vagal, left median, right ulnar, left tibial and right sural nerves ultrasound.

DIAGNOSTIC_TEST

Skin Biopsy

distal leg 3mm punch skin biopsy

Trial Locations (1)

33511

Ahmed Sami Mahmoud Alkotami, Kafr ash Shaykh

All Listed Sponsors
lead

Tanta University

OTHER