Can Ultrasound Detect Diabetic Peripheral Neuropathy?

Distal Symmetric Polyneuropathy (DSPN) Clinical Trial

Official title:

Can Ultrasound Detect Diabetic Peripheral Neuropathy?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261442
• Other study ID #: 10-0435-BE
• Status: Completed
• Phase: N/A
• First received: December 14, 2010
• Last updated: April 25, 2012
• Start date: January 2011
• Est. completion date: February 2012

Study information

• Verified date: June 2010
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: University Health Network
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Distal Symmetric Polyneuropathy (DSPN)
• Peripheral Nervous System Diseases
• Polyneuropathies

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of mean cross-sectional area of the PTN, as measured by sonographic imaging, with the presence of DSPN in diabetic patients.		30 minutes	No
Secondary	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	No
Secondary	Descriptive sonographic appearance of PTN (ie. focal compression, hypo/hyper echogenicity, and texture).		30 minutes	No
Secondary	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	No