Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Jan 2023

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.1 years study duration

Study Start

First participant enrolled

January 1, 2023

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2023

Completed

1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed

2 months until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2024

Completed

Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

May 21, 2023

Last Update Submit

April 8, 2024

Conditions

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

Outcome Measures

Primary Outcomes (12)

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
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
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
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
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
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
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
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
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
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
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
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 Outcomes (4)

Diabetic neuropathy severity assessment using NPS
through study completion, an average of 9 months
Diabetic neuropathy severity assessment TCNS
through study completion, an average of 9 months
Diabetic neuropathy severity assessment using COMPASS-31
through study completion, an average of 9 months
Diabetic neuropathy quality of life evaluation using Euro quality of life -5 dimensions -5 levels scale.
through study completion, an average of 9 months.

Study Arms (3)

Patients with diabetic small fiber neuropathy

Diabetic Patients presented with pure small fiber neuropathy.

Diagnostic Test: Clinical Evaluation/QuestionnairesDiagnostic Test: Nerve Conduction StudyDiagnostic Test: Small fiber electrodiagnostic testsDiagnostic Test: Nerve UltrasoundDiagnostic Test: Skin Biopsy

Patients with diabetic mixed small and large fiber neuropathy

Diabetic Patients presented with mixed small and large fiber neuropathy

Subjects without neuropathy

Healthy subjects without any symptoms and/or signs suggesting neuropathy, and within average IENFD on skin biopsy.

Interventions

Clinical Evaluation/QuestionnairesDIAGNOSTIC_TEST

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)