Diabetes

When we eat, sugars and starches are broken down into glucose, a form of sugar that the body uses for energy. Specialized cells in the pancreas release insulin, a hormone that’s used to unlock cell walls and allow glucose to be used for fuel. People with diabetes either don’t make enough insulin on their own or are unable to properly use insulin. Thus, despite high levels of glucose in the bloodstream, the body’s cells don’t have enough fuel.

According to the Centers for Disease Control and Prevention, about 24 million Americans have diabetes. Type 2 is the most common form, accounting for 90 to 95 percent of all cases. Patients are often overweight and sedentary and can usually control their symptoms with diet, exercise and, sometimes, medications. People with type 1 diabetes don’t make insulin and need regular injections of the hormone to stay alive.

Diabetic Foot Problems

Foot problems in diabetics are typically caused by a combination of two main factors: peripheral neuropathy (nerve damage) and peripheral vascular disease (poor blood flow). Peripheral neuropathy can lead to numbness or a loss of feeling in the legs, feet, arms and hands. Without normal pain sensation, a person with diabetes can have a serious foot ulcer (open wound) and not even realize the injury has occurred. Even a simple blister, callous or sore can develop into a serious, open wound. Peripheral vascular disease contributes to foot complications because not enough healing factors can reach the wound site.

Researchers estimate people with diabetes have a 25 percent lifetime chance of developing a foot ulcer. In some cases, the wound fails to heal, despite intensive treatment. To prevent the infection from spreading, doctors may recommend amputation of the affected part of the body. In the foot, that may mean loss of a toe, part of the foot or part of the leg. The American Diabetes Association reports more than 60 percent of non-traumatic amputations are performed in patients with diabetes.

Excellarate™ for Neuropathic Diabetic Foot Wounds

Researchers are testing a new topical gel for non-healing wounds in patients with diabetic neuropathy, called Excellarate™. The gel is made from bovine collagen and is composed of a gene-activated biocompatible Matrix™. The gel is applied to the wound. Then, Scott Lipkin, D.P.M., Podiatrist/Researcher with Lehigh Valley Health Network in Allentown, PA, says cells migrate into the Matrix and take up an embedded carrier virus (adenovirus). The adenovirus has been genetically altered to stimulate the cells’ release of platelet-derived growth factor-B (PDGF-B), a key component of wound healing. In turn, that sets off the healing process, stimulating the growth of new blood vessels and tissue.

In an early phase 1/ 2 study, 10 out of 15 patients (67 percent) had wound closure within 14 weeks of treatment with Excellarate. Seven of the ten had received just one application of the product. A phase 2b study of about 125 participants showed 48 percent of patients had complete wound closure within 12 weeks after a single application of Excellarate (compared to 31 percent wound closure for patients receiving standard care). The company is now in talks with the FDA to initiate Phase 3 trials with the wound-healing drug. For information on Excellarate™, click here.

For information about the study, click here, then type the trial identification number in the search box: NCT00493051. Information about the study is also available here.

For general information on diabetes and diabetic foot care:

American Diabetes Association

National Institute