Promise for prediabetes

DEAR DR. ROACH: I was diagnosed with prediabetes.

I have had neuropathy in both feet for several years, and a "nonhealing diabetic foot ulcer" on one heel for two years. The ulcer has never completely healed, and it causes some pain on occasion.

Recently, I became aware of a study by a drug company in Atlanta. It appears to be developing a new treatment that shows promise.

Can you tell me about the status of this treatment, and if it is available for use by the public?

ANSWER: I think you are referring to an investigational drug called VM202, which is a gene therapy for people with diabetes and blockages in the arteries leading to a foot ulcer.

The gene (DNA) codes for a protein called "human hepatocyte growth factor," which, when taken up by muscle cells, causes them to secrete this growth factor. This, in turn, stimulates the formation of new blood vessels.

Early trials were encouraging, so the drug is now in phase 3, meaning the company is running a large trial to see whether it is effective. If so, it could be a major advantage in treating this common and difficult problem. Unfortunately, many drugs fail at this stage, either because they are not effective or they have toxicities that were unrecognized in previous smaller studies.

Gene therapy is a relatively new modality, so it may take longer than usual for the Food and Drug Administration to decide whether to approve this drug.