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NCT05993871 Clinical Trial

Diabetic Small Fiber Neuropathy: Clinical, Electrophysiological and Neurosonographic Study

Diabetic Neuropathies Clinical Trial

Official title:
Diabetic Small Fiber Neuropathy: Clinical, Electrophysiological and Neurosonographic Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05993871
Other study ID # 34059/8/20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date January 22, 2024

Study information
Verified date April 2024
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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Study Design

Related Conditions & MeSH terms

Intervention

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)
• Nerve Conduction Study
Routine Nerve Conduction Study.
• Small fiber electrodiagnostic tests
R-R interval analysis, Cutaneous Silent Period and Sympathetic Skin Response.
• Nerve Ultrasound
Bilateral vagal, left median, right ulnar, left tibial and right sural nerves ultrasound.
• Skin Biopsy
distal leg 3mm punch skin biopsy

Locations
Country Name City State
Egypt Ahmed Sami Mahmoud Alkotami Kafr Ash Shaykh

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (16)

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Outcome
Type Measure Description Time frame Safety issue
Primary Demonstrate the findings of UENS in the studied groups Demonstrate the findings of Utah early neuropathy scale in the studied groups to screen for neuropathic symptoms, where overall scores of 4 and more are considered positive. through study completion, an average of 9 months
Primary Demonstrate the findings of TCNS in the studied groups Demonstrate the findings of Toronto clinical neuropathy scale in the studied groups, to screen for the neuropathic symptoms where overall scores of 6 and more are considered positive. through study completion, an average of 9 months
Primary Demonstrate the findings of EuroQOL-5D-5L in the studied groups Demonstrate the findings of Euro quality of life -5 dimensions -5 levels scale in the studied groups, where lesser scores suggest a lower overall quality of life. through study completion, an average of 9 months
Primary Demonstrate the findings of nerve conduction studies protocol of the performed nerves in the studied groups. Demonstrate the findings of nerve conduction studies (NCS) to define neuropathy in the studied groups, which include: unilateral sensory studies of sural, superficial peroneal and ulnar nerves, and motor studies of tibial, peroneal, and ulnar motor nerves with ulnar and tibial F wave latencies. Nerves were evaluated according to a recommended protocol for NCS postulated by the American Academy of Neurology in conjunction with the American Association of Electrodiagnostic Medicine and the American Academy of Physical Medicine and Rehabilitation, which include an abnormality of any nerve conduction attribute is in two separate nerves, one of which must be the sural nerve. through study completion, an average of 9 months
Primary Demonstrate the findings of cutaneous silent period in the studied groups. Demonstrate the findings of cutaneous silent period on stimulating left median nerve and recording from the left abductor pollicis brevis muscle, and on stimulating right sural nerve and recording from the tibialis anterior muscle, where abnormal results in encountered when there is delayed onset and/or end latencies, and/or decreased or absent duration. through study completion, an average of 9 months
Primary Demonstrate the findings of sympathetic skin response in the studied groups. Demonstrate the findings of sympathetic skin response on hand-to-hand stimulation of both median nerves, and foot-to-foot stimulation of both tibial nerves, where abnormal result is encountered when there is absent response, or delayed onset latency and/or decreased amplitude. through study completion, an average of 9 months
Primary Demonstrate the findings of Ewing battery in the studied groups. Demonstrate the findings of Ewing battery in the studied groups, where findings are recorded in all the 5 domains of the battery as normal or borderline or abnormal. Total score ranges from 0-5, and cardiovascular autonomic neuropathy is diagnosed according to the findings o fthe battery, where the findings are classified as follows
Normal: If all tests are normal, or one test is borderline.
Early: One heart rate test is abnormal or two are borderline.
Definite: At least two heart rate tests are abnormal
Severe: At least two heart rate tests are abnormal plus either at least one blood pressure test is abnormal or both tests are borderline.
Atypical: Any other undefined combination.
Further simplified classification is either normal (including normal or early findings) and abnormal (including definite, severe and atypical findings).		 through study completion, an average of 9 months
Primary Demonstrate the findings of nerve ultrasound CSA of both vagal nerves. Demonstrate the findings of nerve ultrasound cross-sectional area of both vagal nerves scanned opposite to the cricoid cartilage in the studied groups. through study completion, an average of 9 months
Primary Demonstrate the findings of nerve ultrasound CSA of right sural nerve. Demonstrate the findings of nerve ultrasound cross-sectional area of right sural nerve at the distal calf in the studied groups. through study completion, an average of 9 months
Primary Demonstrate the findings of nerve ultrasound CSA of left tibial nerve. Demonstrate the findings of nerve ultrasound cross-sectional area of left tibial nerve at the distal calf in the studied groups. through study completion, an average of 9 months
Primary Demonstrate the findings of nerve ultrasound CSA of left median nerve. Demonstrate the findings of nerve ultrasound cross-sectional area of left median nerve at the mid-forearm in the studied groups. through study completion, an average of 9 months
Primary Demonstrate the findings of nerve ultrasound CSA of right ulnar nerve. Demonstrate the findings of nerve ultrasound cross-sectional area of right ulnar nerve at the mid-forearm in the studied groups. through study completion, an average of 9 months
Secondary Diabetic neuropathy severity assessment using NPS Diabetic neuropathy severity assessment using 11-item Numeric Pain Scale overall score. through study completion, an average of 9 months
Secondary Diabetic neuropathy severity assessment TCNS Diabetic neuropathy severity assessment using Toronto clinical neuropathy scale, overall score. through study completion, an average of 9 months
Secondary Diabetic neuropathy severity assessment using COMPASS-31 Diabetic neuropathy severity assessment using The Composite Autonomic Symptom Score-31, overall score. through study completion, an average of 9 months
Secondary Diabetic neuropathy quality of life evaluation using Euro quality of life -5 dimensions -5 levels scale. Diabetic neuropathy quality of life evaluation using EuroQOL-5D-5L index value. through study completion, an average of 9 months.
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