DeGette Begins Push For Approval Of Cuban Drug For Foot Ulcers

DENVER (CBS4) - When Mason McClatchey applied for grad school, he set out with an ambitious goal: to advance diabetes research. He's a scientist and he's a diabetic.

"I started realizing there were a lot of tools that I could envision that I do not have, and science helps those who help themselves (so) I figured I would go make them," he said.

Among the missing tools was an effective treatment for foot ulcers, a common complication for diabetics that sometimes leads to amputation.

Then came a breakthrough out of Cuba. It's a growth factor called Heberprot-P that healed foot ulcers in 70 percent of patients.

"So we became very interested in the potential this drug might have in the U.S.," said Rep. Diana DeGette (D-Denver) who is chairwoman of the Congressional Diabetes Caucus.

The results in Cuba were so promising that the FDA approved clinical trials of Heberprot-P in America. But, because of the trade embargo, the State Department blocked sale of the drug, making trials useless. Now that has changed.

DeGette traveled to Cuba and is now pushing to start clinical trials in the United States after President Barack Obama eased trade restrictions last month.

"Because if the clinical trials work really work -- and it has shown it has worked incredibly well in Cuba and other countries -- this could be huge life changing event for many diabetics in this country," she said.

McClatchey told CBS4 he's hopeful.

"I kind of like having my feet. They're useful for the things I like to do with my life, so I'm tentatively excited about the idea that we might have another weapon in the arsenal," he said.

Dr. Jane Reusch, who sits on the board of the National Diabetes Foundation, is also cautiously optimistic.

"In this study that allowed registration in Cuba they only studied 75 patients. And since there are 73,000 amputations in U.S. each year and 60 percent of them occur in people with diabetes, you want to make sure that this drug is safe as well efficatious," Reusch said.

DeGette said she will pull the leadership of the Diabetes Caucus together with the State Department and FDA to expedite trials.

The Diabetes Caucus is the largest caucus in Congress, with more than 360 Democrats and Republicans.