Ultrasonographic Evaluation of Diabetic Neuropathy

NCT02308059 | Completed

• 1 other identifier: TF2012BAP13
• Study Type: observational
• Target: 106
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Pain scores on the visual analog scale

  3 years

Secondary Outcomes (1)

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

  3 years

Study Arms (2)

Patients with diabetes mellitus

Group I; the patients with diabetes mellitus who had peripheral neuropathy as diagnosed.

Other: Ultrasonographic evaluation of nerves in diabetic patients

Control

Group II; healthy volunteers

Other: Ultrasonographic evaluation of nerves of healthy volunteers

Interventions

Ultrasonographic evaluation of nerves in diabetic patients OTHER

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

Also known as: ultasonographic evaluation

Patients with diabetes mellitus

Ultrasonographic evaluation of nerves of healthy volunteers OTHER

evaluation of peripheral nerves and correlated with group I

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients in a University Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Officials

• Bayram Kelle

  Çukurova University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 4, 2014
• Study Start: April 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 4, 2014

Record last verified: 2014-12