New Patch Shows Promise in Healing Diabetic-Related and Pressure Ulcers
Geoffrey Gurtner, MD, the Johnson & Johnson professor of surgery, talks about the findings from a recent Stanford study that could lead to the development of a new transdermal patch to improve treatment for diabetic-related and pressure ulcers.
February 2015
Researchers at the Stanford University School of Medicine have developed a skin patch that slowly delivers a drug that enhances the healing of diabetes-related ulcers. The patch, which was tested in mice, can also serve as a way to prevent future ulcer formation and can be used to treat pressure ulcers, according to the senior author of the study Geoffrey Gurtner, MD, the Johnson & Johnson professor of surgery. Sharing lead authorship of the paper describing findings of the new research are Dominik Duscher, MD, a postdoctoral scholar in surgery, and Evgenios Neofytou, MD, an instructor at the Stanford Cardiovascular Institute.
According to the study, which was published online in the December 22, 2014 issue of Proceedings of the National Academy of Sciences, the high levels of blood sugar in people with diabetes compromise the body's ability to form new blood vessels essential for wound healing. The study also discovered a potential treatment for the problem: deferoxamine, or DFO, a drug already approved by the Food and Drug Administration to treat hemochromatosis, a condition in which too much iron accumulates in the body. DFO can correct the diabetes-impaired expression of a protein that supports new vascular growth.
But DFO is too toxic in the dose required for the long-term treatment of diabetic wounds. So the researchers developed an alternative delivery method, a patch applied to the skin that slowly emits the medication into the wounded tissue and skin.
In the mouse studies, Gurtner says, the wounds healed more quickly, and the quality of the new skin was even better than the original. This higher quality skin, with a thicker dermis and more collagen, is also less likely to re-ulcerate at the same site, he says.
Among the more than 29 million people in the United States with either type-1 or type-2 diabetes, an estimated 15 percent develop ulcers. The ulcers, sores or open wounds that usually occur on the foot, become a secondary health condition that leads to prolonged disability, high rates of recurrence and increased mortality.
There are currently no effective therapies to prevent diabetic ulcer formation and only modestly effective treatments to accomplish healing. "Right now, the only thing we can tell these patients is to take better care of their feet," says Gurtner. "There's not a lot we can do to prevent their skin from breaking down. This patch would give us another arrow in the quiver that could potentially lessen their risk of developing a foot ulceration."
Possible treatment for pressure ulcers
This new patch technology, says Gurtner, may also prove effective in preventing pressure ulcers, which are a major source of morbidity and mortality in patients with neurologic injury or the elderly. Although the mechanisms at a biological level are different in aging or pressure sores than they are in diabetes, the same molecule is effective in both processes. Pressure ulcers on the heels and sacrum are among the most common conditions encountered in acutely hospitalized patients or those requiring long-term institutional care. An estimated 2.5 million pressure ulcers are treated each year in acute care facilities in the United States alone.
"The actor Christopher Reeve actually died from a pressure ulcer and not his spinal cord injury, which really emphasizes the extremely limited therapeutic options for these patients," adds Gurtner.
Rapid translation
Because deferoxamine is already approved by the FDA and a well-understood drug, Gurtner and his team can take an expedited pathway to beginning clinical trials of the transdermal patch, he says, enrolling patients into what looks like a Phase 2 trial or study. Once the trial is ready to launch, patients at the Stanford Advanced Wound Care Center in Redwood City will be first to be enrolled. The Wound Care Center cares for patients with new and chronic wounds, including those with diabetic ulcers, venous ulcers, arterial ulcers, pressure ulcers, chronic infections, radiation wounds, peripheral vascular disease, venous insufficiencies and osteomyelitis. It is also a translational clinical trials unit.
Patients who could ultimately benefit from the transdermal patch, says Gurtner, are those with vascular disease or neuropathy that can't be corrected and who are thought to be at high risk of ulceration. To refer a patient for advanced wound care, call the physician referral line at 866-742-4811.
Adapted with permission from an article by Sara Wykes, "Skin patch could help heal, prevent diabetic ulcers, study finds."