Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy

This study is currently active

Diabetic peripheral neuropathy is nerve damage caused by chronically high blood sugar and diabetes. It leads to numbness, loss of sensation, and sometimes pain in your feet, legs, or hands. It is the most common complication of diabetes.

We are looking for participants ages 18 to 75 who have DPN in their legs/feet. This is a double blinded study, which means neither you nor the study doctor will know what medication group you will be placed into. You will be randomly assigned by chance to receive either study medication or placebo (inactive medication); you will have 50% chance of receiving study medication. The study is 1 year long. There are 11 office visits to our site. Pleas fill out the survey and we will contact you with more information.

The purpose of this study is to determine the safety and efficacy of bilateral intramuscular injections of VM202 versus placebo in the treatment of painful diabetic neuropathy.

Peripheral neuropathy is a serious complication of diabetes. This form of neuropathy carries a high risk of pain, trophic changes and autonomic dysfunction. Treatment of diabetic peripheral neuropathy (DPN) is based on either pathogenetic mechanisms or symptomatic relief. A number of clinical trials have established symptomatic treatment but for pathogenetic mechanisms, the only proven treatment strategy is strict glycemic control. 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. The results from previous studies suggest that VM202 provides the same magnitude of pain relief as reported with pregabalin or gabapentin.

Inclusion Criteria:

  1. Age 18 to 75;
  2. Documented history of Type I or II diabetes;
  3. No significant changes anticipated in diabetes medication regimen;
  4. No new symptoms associated with diabetes within the last 3 months prior to study entry;
  5. Diagnosis of painful diabetic peripheral neuropathy in both lower extremities woth pain for at least 6 months;

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427464

Participate in a Study

Submit the form and a clinical study expert will get in touch with you.

Want to know more about our clinical trials?

Leave a Reply