Can Ultrasound Detect Diabetic Peripheral Neuropathy?

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT01261442
Collaborator
(none)
100
1
13
7.7

Study Details

Study Description

Brief Summary

The cross sectional area of posterior tibial nerve (PTN) is increased in diabetic patients with distal symmetric polyneuropathy (DSPN) as compared to diabetic patients without DSPN. This study aims to evaluate whether the cross sectional area of the Posterior Tibial Nerve (PTN) as measured by ultrasound is increased in patients with distal symmetric polyneuropathy (DSPN) as compared to diabetic patients without DSPN.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Nerve Conduction Study (NCS)

Detailed Description

Regional anesthesia is associated with a low frequency of neurologic injury that can result in permanent deficit. It is believed that patients with neuropathies might be at higher risk of injury but detailed investigation of the diabetic patient is lacking yet anesthetic practices may be altered nevertheless. This study intends to investigate the appearance and sonographic qualities, as well as electrophysiologic measures, of the posterior tibial nerve (PTN) in diabetic patients undergoing nerve conduction studies in order to compare PTN characteristics between diabetic patients with peripheral neuropathy to those without. Ultimately, we hope that ultrasound, a commonly used non-invasive tool, will be able to assist in the identification of patients at higher risk of injury from regional anesthesia

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Can Ultrasound Detect Diabetic Peripheral Neuropathy?
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Diabetic patients with DSPN

Procedure: Nerve Conduction Study (NCS)
An NCS will be performed on each patient to confirm or exclude DSPN. Following this, a systematic ultrasound examination of the posterior tibial nerve will be performed for all the patients.

Diabetic patients without DSPN

Procedure: Nerve Conduction Study (NCS)
An NCS will be performed on each patient to confirm or exclude DSPN. Following this, a systematic ultrasound examination of the posterior tibial nerve will be performed for all the patients.

Outcome Measures

Primary Outcome Measures

  1. Association of mean cross-sectional area of the PTN, as measured by sonographic imaging, with the presence of DSPN in diabetic patients. [30 minutes]

Secondary Outcome Measures

  1. Association of mean cross-sectional area of the PTN, and the severity of DSPN (graded mild, moderate, and severe) in diabetic patients with peripheral neuropathy. [30 minutes]

  2. Descriptive sonographic appearance of PTN (ie. focal compression, hypo/hyper echogenicity, and texture). [30 minutes]

  3. Association of mean cross-sectional area of the PTN, and the severity of DSPN (graded mild, moderate, and severe) in diabetic patients with peripheral neuropathy. [30 minutes]

    The criteria for assessment of severity of DSPN is as follows: No neuropathy: diabetic patients with no sign or symptoms of neuropathy, and normal NCS; Incipient neuropathy: diabetic patients with signs, and symptoms of neuropathy, and normal NCS; Subclinical neuropathy: Diabetic patients without signs of symptoms of neuropathy and abnormal NCS; Moderate neuropathy: diabetic patients with signs and symptoms of neuropathy and abnormal NCS; Severe neuropathy: diabetic patients with signs and symptoms of neuropathy and abnormal NCS, with absence of the sural nerve response.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Type I diabetic patients (diagnosed more than 5 years), and type II diabetic patients scheduled for routine NCS.
Exclusion Criteria:
  • Non-diabetic neuropathy caused by genetic, metabolic and inflammatory diseases as well as toxic agents and drug induced (eg. chemotherapy agents)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toronto Western Hospital Toronto Ontario Canada M5T 2S8

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01261442
Other Study ID Numbers:
  • 10-0435-BE
First Posted:
Dec 16, 2010
Last Update Posted:
Apr 26, 2012
Last Verified:
Jun 1, 2010

Study Results

No Results Posted as of Apr 26, 2012