Diabetic Neuropathy
Conditions
Brief summary
To determine the effect of Ruboxistaurin on small fiber function.
Interventions
DRUGRuboxistaurin
Sponsors
Chromaderm, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have Type 1 or Type 2 diabetes mellitus * Patients must have bilateral sensorimotor distal peripheral neuropathy attributable to diabetes mellitus * Patients must have blood glucose control measured as HbA1c=\<11% * Patients must be 18 years of age or older. * Patients must be able to return to all follow-up visits
Exclusion criteria
* Patients must not have symptoms of diabetic peripheral neuropathy that cannot be distinguished from other etiologies * Patients must not have a neurologic disease or neuropathy from a cause other than diabetes mellitus that would interfere with correct evaluation of symptomatic peripheral neuropathy. * Patient currently has uncontrolled high blood pressure * You have other medical problems that your doctor feels would make it unsafe for you to participate in this study such as liver or kidney problems * You are a woman of childbearing age and unwilling or unable to use effective contraceptive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objectives of this study is to evaluate the effect of ruboxistaurin on subjects with diabetic peripheral polyneuropathy | — |
Secondary
| Measure | Time frame |
|---|---|
| Ruboxistaurin will improve quantitative sensory testing and increase nerve fiber density in subjects with diabetic peripheral polyneuropathy. | — |
Countries
United States
Outcome results
None listed