Study Summary:
PURPOSE: The study doctor will give the study drug to some people in the study to see if it is safe and to see if it can help them with their diabetic peripheral neuropathy. Some patients will receive the study drug and one out of three will receive placebo, a substance that looks like Ranirestat but has no active ingredient.
DURATION: If you were to qualify to participate in this study, your participation would be for approximately two years. The study consists of three periods: pre-randomization, double-blind, and follow-up. The pre-randomization period consists of two study visits (or more if we need to repeat some tests) and lasts 1 month. The double-blind period consists of 10 study visits and lasts 24 months. The follow-up period consists of one study visit and lasts 1 month.
Qualified Participants Must:
• Be 18-75 years of age
•
Have diagnosis of Diabetes type I or II
•
Have neuropathy symptoms (pain, tingling, numbness, burning) originating in feet
•
Not have hypothyroidism or vitamin B12 deficiency
•
Not have history of diabetic foot ulcer
Qualified Participants May Receive:
Patients that qualify for the trial will receive, at no cost; study related procedures, such as physical Exams, ECG, and laboratory work, and investigational medication for the duration of the study. You may also be compensated for your time and travel.