Ultrasonographic Evaluation of Diabetic Neuropathy

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

Diabetic Peripheral Neuropathy: Correlation Between Ultrasound Findings and Clinical Features

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308059
• Other study ID #: TF2012BAP13
• Status: Completed
• Phase: N/A
• First received: December 1, 2014
• Last updated: December 2, 2014
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• Ultrasonographic evaluation of nerves in diabetic patients
Ultrasonographic evaluation of peripheral nerves in patients with diabetes mellitus which have peripheral neuropathy
• Ultrasonographic evaluation of nerves of healthy volunteers
evaluation of peripheral nerves and correlated with group I

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores on the visual analog scale		3 years	No
Secondary	Neuropathic pain scores on the Leeds Assessment of Neuropathic Symptoms and Signs pain scale		3 years	No