Can Ultrasound Detect Diabetic Peripheral Neuropathy?

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.

Study Overview

• Status: Completed
• Conditions: Distal Symmetric Polyneuropathy (DSPN)
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
Descriptive sonographic appearance of PTN (ie. focal compression, hypo/hyper echogenicity, and texture).		30 minutes
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.	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.	30 minutes

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: December 14, 2010
• First Submitted That Met QC Criteria: December 14, 2010
• First Posted (Estimate): December 16, 2010

Study Record Updates

• Last Update Posted (Estimate): April 26, 2012
• Last Update Submitted That Met QC Criteria: April 25, 2012
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: regional anesthesia; diabetic peripheral neuropathy; nerve conduction study; distal symmetric polyneuropathy; posterior tibial nerve
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies
• Other Study ID Numbers: 10-0435-BE