NCT05993871

Diabetic Small Fiber Neuropathy: Clinical, Electrophysiological and Neurosonographic Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This case-control observational study is aiming to evaluate patients with diabetic small fiber neuropathy in the Egyptian. Diabetic small fiber neuropathy was defined as both of the following: A. Typical clinical symptoms of SFN such as burning or sharp pain in toes and feet, and on clinical examination: loss of small fiber modalities (pinprick and temperature), hyperalgesia, allodynia, and/or autonomic signs. B. Reduced intraepidermal nerve fiber density (IENFD) in distal leg skin punch biopsy. The study includes 3 groups: Group I: Patients with diabetic small fiber neuropathy Group II (Control Group): Patients with diabetic mixed small and large fiber neuropathy Group III (Control Group): Subjects without peripheral neuropathy Clinical evaluation includes: Neuropathic Pain 4 (DN4) questionnaire, 11-point Numeric Pain Scale (NPS), Utah Early Neuropathy Scale (UENS), Toronto Clinical Neuropathy Scale (TCNS), Composite Autonomic Symptom Score (COMPASS-31), an Arabic version, and several anthropometric measures; including: body weight in kilograms, height in centimeters, waist circumference measured in centimeters at the top of the iliac crest, and systolic "SBP" and diastolic "DBP" blood pressure measurement in mmHg. Electrodiagnostic evaluation includes: routine nerve conduction study, cutaneous silent period by stimulating left median nerve and right sural nerve and recording from the abductor pollicis brevis and tibialis anterior muscles, respectively, bilateral hand-to hand and foot-to-foot sympathetic skin response, and Ewing battery using R-R interval analysis, in addition to the blood pressure tests. Neurosonographic evaluation includes: bilateral vagal nerve scan at the mid-neck lateral to the thyroid cartilage, left median and right ulnar nerves scan at the mid-forearm, left tibial nerve at the distal ankle 2 to 4 fingerbreadths proximal to the medial malleolus, and right sural nerve 2 to 4 fingerbreadths proximal to the lateral malleolus. Nerves are evaluated for transverse cross-sectional area (CSA). Severity and outcome measures are assessed using: NPS, TCNS, COMPASS-31, and the index score of Euro Quality of Life -5 Dimensions -5 Levels (EuroQOL-5D-5L), the Arabic version.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-06-30
• Completion: 2024-01-22
• First posted: 2023-08-15
• Last updated: 2024-04-10

Locations

1 site across 1 country: Egypt