Painful Diabetic Neuropathy Clinical Trial
Official title:
A Phase I/II, Open Label, Dose-Escalation Study to Assess the Safety and Tolerability of VM202 in Patients With Painful Diabetic Peripheral Neuropathy
The purpose of this study is to assess the safety and tolerability of injecting VM202 in the leg muscle in patients with painful diabetic neuropathy (DPN). The study will also assess the potential of VM202 to reduce the pain associated with DPN.
Peripheral neuropathy is a serious complication of diabetes. This form of neuropathy carries
a high risk of pain, trophic changes and autonomic dysfunction.
Currently, there are no approved drugs or interventional strategies known to halt or reverse
the progression of DPN. Treatments target pain reduction, physical function improvement,
reduction of psychological distress, and quality of life improvements.
There is currently no effective treatment for diabetic neuropathy, and good glycemic control
is the only way to minimize the risk of occurrence. Clearly, it would be desirable to
prevent, impede, or reverse the disrupting and often life-threatening manifestations of
peripheral neuropathy by stimulating growth or regeneration of peripheral nerve axons.
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