Northern California Research is conducting a study for diabetic peripheral neuropathy (DPN). DPN is a type of nerve damage that can occur if you have diabetes. This study is for men and women who are experiencing painful diabetic peripheral neuropathy in both lower extremities (legs). The specific events that result in painful diabetic neuropathy are not well understood, but high blood sugar, reduced blood flow in the limbs, and changes in the blood vessels are thought to result in damage to the nerves in the affected areas. Stimulating the growth of new blood vessels may stimulate growth or regeneration of nerves and may reduce pain.
Researchers have discovered that a protein called HGF (hepatocyte growth factor) that your body naturally produces in small amounts can cause the growth of new blood vessels and protect nerves. Unfortunately, your body only makes a small amount of this protein and not always in the areas where you need it. Researchers have found a way to increase the amount of HGF in your legs. They have isolated the genes responsible for directing the production of HGF and have designed a product that can be injected into your leg. The study medication includes the HGF genes.
The purpose of this study is to evaluate the study medication in comparison to a placebo in order to determine if it relieves pain associated with painful diabetic neuropathy. We are looking for participants ages 18 to 75 who have painful DPN in their legs and/or 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 (incavtive medication); you will have 50% chance of receiving study medication. The study is length is 12 months (1 year) and includes 11 office visits to our site.