Ultrasonographic Evaluation of Diabetic Neuropathy | NCT02308059

Studies
Ultrasonographic Evaluation of Diabetic Neuropathy

NCT02308059

Sponsor

Cukurova University

Status

Completed

Last Update Posted

Dec 4, 2014Estimated

Enrollment

106Actual

Phase

Not provided

Conditions

Diabetic Peripheral Neuropathy

Interventions

Ultrasonographic evaluation of nerves in diabetic patients
Ultrasonographic evaluation of nerves of healthy volunteers

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Dec 1, 2014

First Submission Date that Met QC Criteria

Dec 2, 2014

First Posted Date

Dec 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2014

Last Update Posted Date

Dec 4, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ultrasonographic evaluation of nerves in diabetic patients	Other	Ultrasonographic evaluation of peripheral nerves in patients with diabetes mellitus which have peripheral neuropathy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain scores on the visual analog scale		3 years

Secondary Outcomes

Measure	Description	Time Frame
Neuropathic pain scores on the Leeds Assessment of Neuropathic Symptoms and Signs pain scale		3 years

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Outpatients in a University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bayram Kelle	Çukurova University, Faculty of Medicine	Principal Investigator

Locations

Not provided