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Can Ultrasound Detect Diabetic Peripheral Neuropathy?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01261442
First received: December 14, 2010
Last updated: April 25, 2012
Last verified: June 2010
History of Changes
  Purpose

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 Intervention
Distal Symmetric Polyneuropathy (DSPN)
 Procedure: Nerve Conduction Study (NCS)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Can Ultrasound Detect Diabetic Peripheral Neuropathy?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Association of mean cross-sectional area of the PTN, as measured by sonographic imaging, with the presence of DSPN in diabetic patients. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Descriptive sonographic appearance of PTN (ie. focal compression, hypo/hyper echogenicity, and texture). [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

    The criteria for assessment of severity of DSPN is as follows:

    1. No neuropathy: diabetic patients with no sign or symptoms of neuropathy, and normal NCS;
    2. Incipient neuropathy: diabetic patients with signs, and symptoms of neuropathy, and normal NCS;
    3. Subclinical neuropathy: Diabetic patients without signs of symptoms of neuropathy and abnormal NCS;
    4. Moderate neuropathy: diabetic patients with signs and symptoms of neuropathy and abnormal NCS;
    5. Severe neuropathy: diabetic patients with signs and symptoms of neuropathy and abnormal NCS, with absence of the sural nerve response.


Enrollment: 100
Study Start Date: January 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

100 adult diabetic patients scheduled to undergo a nerve conduction study.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261442

Locations
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01261442     History of Changes
Other Study ID Numbers: 10-0435-BE
Study First Received: December 14, 2010
Last Updated: April 25, 2012
Health Authority: Canada: University Health Network

Keywords provided by University Health Network, Toronto:
distal symmetric polyneuropathy
diabetic peripheral neuropathy
posterior tibial nerve
regional anesthesia
nerve conduction study

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Polyneuropathies
Diabetic Neuropathies
Neuromuscular Diseases
 Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013