The Effect of Ruboxistaurin on Small Fiber Function
| Status: | Completed |
|---|---|
| Conditions: | Diabetic Neuropathy |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/27/2016 |
| Start Date: | October 2004 |
| End Date: | November 2005 |
The Effect of Ruboxistaurin Mesylate (LY333531) on Small Fiber Function as Measured by Microvascular Skin Blood Flow, C-Fiber Quantitations in Skin and Quantitative Sensory Testing of Cold and Heat.
To determine the effect of Ruboxistaurin on small fiber function.
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.
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