Recent developments in the assessment of efficacy in clinical trials of diabetic neuropathy.

A large number of measures may be employed in clinical practice and for epidemiologic studies to quantify and risk stratify diabetic patients with neuropathy. However, not all measures are suitable for assessing the benefits of therapeutic intervention. Therefore, for the purpose of this review we focus on measures that may be employed to define the efficacy of interventions in clinical trials of human diabetic neuropathy. Two major types of end points are used: 1) those that assess symptoms for defining efficacy in painful diabetic neuropathy, and 2) those that assess neurologic deficits that assess the effects of treatments that may prevent further degeneration or promote repair.