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Diabetic Small Fiber Neuropathy: Clinical, Electrophysiological and Neurosonographic Study

NCT05993871 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2024-04-10

No results posted yet for this study

Summary

The aim of work is to study the clinical, electrodiagnostic and neurosonographic characteristics of diabetic patients with small fiber neuropathy in the Egyptian population, and to evaluate both the diagnostic and the prognostic impact of the studied factors on the neuropathy severity and quality of life.

Conditions

  • Small Fiber Neuropathy
  • Diabetic Neuropathies
  • Autonomic Neuropathy
  • Diabetic Peripheral Neuropathy
  • Painful Diabetic Neuropathy
  • Diabetic 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

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-06-30
Completion
2024-01-22

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05993871 on ClinicalTrials.gov