Clinical trial NCT01261442: Can Ultrasound Detect Diabetic Peripheral Neuropathy?
Official title: Can Ultrasound Detect Diabetic Peripheral Neuropathy?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Symmetric Polyneuropathy (DSPN)
Keywords: distal symmetric polyneuropathy
diabetic peripheral neuropathy
posterior tibial nerve
regional anesthesia
nerve conduction study
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 adult diabetic patients scheduled to undergo a nerve conduction study.

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

Eligibility criteria: 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)

Primary outcomes:
measure: Association of mean cross-sectional area of the PTN, as measured by sonographic imaging, with the presence of DSPN in diabetic patients.
timeFrame: 30 minutes
Secondary outcomes:
measure: 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.
timeFrame: 30 minutes
measure: Descriptive sonographic appearance of PTN (ie. focal compression, hypo/hyper echogenicity, and texture).
timeFrame: 30 minutes
measure: 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.
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
References: