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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02308059
Other study ID # TF2012BAP13
Secondary ID
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


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
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