Can Ultrasound Detect Diabetic Peripheral Neuropathy?

Study Overview
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Brief Summary
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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
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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

Official Title
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Can Ultrasound Detect Diabetic Peripheral Neuropathy?

Conditions
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Distal Symmetric Polyneuropathy (DSPN)

Intervention / Treatment
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* Procedure: Nerve Conduction Study (NCS)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic patients with DSPN<br> | Procedure: Nerve Conduction Study (NCS)<br>* 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.<br>|
| Diabetic patients without DSPN<br> | Procedure: Nerve Conduction Study (NCS)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distal symmetric polyneuropathy, diabetic peripheral neuropathy, posterior tibial nerve, regional anesthesia, nerve conduction study