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Completed

NCT Number: NCT02308059

Ultrasonographic Evaluation of Diabetic Neuropathy

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.

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Key information

Conditions

Diabetic Peripheral Neuropathy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasonographic evaluation of nerves in diabetic patients

Other

Ultrasonographic evaluation of peripheral nerves in patients with diabetes mellitus which have peripheral neuropathy

Other names: ultasonographic evaluation

Ultrasonographic evaluation of nerves of healthy volunteers

Other

evaluation of peripheral nerves and correlated with group I

Primary outcomes

  1. Pain scores on the visual analog scale

    Time frame: 3 years

Secondary outcomes

  1. Neuropathic pain scores on the Leeds Assessment of Neuropathic Symptoms and Signs pain scale

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Diabetic Peripheral Neuropathy: Correlation Between Ultrasound Findings and Clinical Features

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 4, 2014
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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