Completed

NCT Number: NCT01261442

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.

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Key information

Conditions

Distal Symmetric Polyneuropathy (DSPN)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nerve Conduction Study (NCS)

Procedure

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.

Primary outcomes

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

Secondary outcomes

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
Descriptive sonographic appearance of PTN (ie. focal compression, hypo/hyper echogenicity, and texture).

Time frame: 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.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Dec 16, 2010
Registry last updated: Apr 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.