The Effect of Pregabalin on Pain Related to Walking in Patients With Diabetic Peripheral Neuropathy

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis of this study is that pregabalin, 150 mg bid, will reduce general daytime pain in patients diagnosed with diabetic peripheral neuropathy and that it will also reduce the level of pain associated with walking. Consequently, it is hypothesized that the reduction in pain will result in an increase in the amount of walking they do during the day, improvements in their gait, balance, risk of falls and sleep patterns.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Virginia Medical School
• Collaborator: Old Dominion University
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Individuals with painful, peripheral neuropathy (ages 40-75 years) and type 2 diabetes (n=40).

Exclusion Criteria:

• Active ocular or systemic disease

• Recent or recurrent history of musculoskeletal injury,

• Presence of neurological conditions or idiopathic neuropathy

• History of or vertigo

• Use of an aid while walking or difficulty with standing upright

• Visible tremor or uncorrected visual deficits.

• Presence of type 1 diabetes mellitus (defined as C-peptide < 1 ng/ml or diabetes onset at < 35 years of age in a non-obese patient).

• Presence of diabetic retinopathy that is more severe than "background" level.

• Presence of diabetic nephropathy

• Presence of clinically significant neuropathy that is clearly of non-diabetic origin, e.g. alcoholic or autoimmune.

• Bilateral amputation of lower extremities or foot ulcers involving the great toes.

• Presence of neuroarthropathy (Charcot deformity) is allowable.

• History of major macrovascular events such as myocardial infarction or stroke within the past 6 months.

• Patients with moderate or severe hepatic insufficiency or abnormalities of liver function.

• Presence of significant pedal edema.

• Other serious medical conditions that in the opinion of the investigator, would compromise the subject's participation in the study.