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Clinical Trials/NCT02308059
NCT02308059
Completed
Not Applicable

Diabetic Peripheral Neuropathy: Correlation Between Ultrasound Findings and Clinical Features

Cukurova University0 sites106 target enrollmentApril 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Peripheral Neuropathy
Sponsor
Cukurova University
Enrollment
106
Primary Endpoint
Pain scores on the visual analog scale
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The current study aimed to evaluate the cross-sectional area (CSA) of peripheral nerves in people with diabetic peripheral neuropathy using ultrasonography and correlate the CSA with clinical and demographic data.

Detailed Description

Patients with diabetic peripheral neuropathy (n=53) and a matched healthy control group (n=53) underwent blinded ultrasonography imaging of the sciatic, tibial and median nerves. Matching was performed according to patient body mass index (BMI), sex and age. CSAs of the nerves were recorded, and the associations between pain intensity (measured with a visual analog scale \[VAS\]), the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale, diabetes mellitus duration, BMI, HbA1c and blood glucose levels were evaluated.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
December 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bayram Kelle

Director

Cukurova University

Eligibility Criteria

Inclusion Criteria

  • type 2 diabetes mellitus
  • Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scores ≥ 12
  • probable diabetic peripheral neuropathy according to the diabetic peripheral neuropathy criteria.
  • Exclusion Criteria
  • type 1 diabetes mellitus
  • hypothyroidism
  • LANSS pain scale scores \< 12
  • body mass index (BMI) \> 35
  • current pregnancy
  • histories of hereditary neuropathy, inflammatory neuropathy, nerve trauma, or other known causes of polyneuropathy; and the use of anti-neuropathic drugs.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Pain scores on the visual analog scale

Time Frame: 3 years

Secondary Outcomes

  • Neuropathic pain scores on the Leeds Assessment of Neuropathic Symptoms and Signs pain scale(3 years)

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