Can Ultrasound Detect Diabetic Peripheral Neuropathy?

Completed

• Conditions: Distal Symmetric Polyneuropathy (DSPN)
• Interventions: Procedure: Nerve Conduction Study (NCS)

• Registration Number: NCT01261442
• Lead Sponsor: University Health Network, Toronto

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.

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 Timeline

• Status Verified: 2010-06
• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-16
• Study Start: 2011-01
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-04-25
• Last Update Posted: 2012-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Type I diabetic patients (diagnosed more than 5 years), and type II diabetic patients scheduled for routine NCS.

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Exclusion Criteria

• Non-diabetic neuropathy caused by genetic, metabolic and inflammatory diseases as well as toxic agents and drug induced (eg. chemotherapy agents)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic patients with DSPN	Nerve Conduction Study (NCS)	-
Diabetic patients without DSPN	Nerve Conduction Study (NCS)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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: 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.
Descriptive sonographic appearance of PTN (ie. focal compression, hypo/hyper echogenicity, and texture).	30 minutes

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada