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DIABETIC FOOT ULCERS.
What is a Diabetic Foot Ulcer?
A diabetic foot ulcer is an open sore or wound that occurs in approximately 15 percent of patients with diabetes and is commonly located on the bottom of the foot. Of those who develop a foot ulcer, 6 percent will be hospitalized due to infection or other ulcer-related complication.
The number of people with diabetes is increasing in both the United States and around the world. Diabetes currently affects nearly 26 million Americans. Because diabetes causes too much sugar (glucose) to stay in your bloodstream, it can damage many parts of the body, including the heart, blood vessels, nerves, eyes, and kidneys.
Anyone who has diabetes can develop a foot ulcer. Native Americans, African Americans, Hispanics, and older men are more likely to develop ulcers. People who use insulin are at higher risk of developing a foot ulcer, as are patients with diabetes-related kidney, eye, and heart disease. Being overweight and using alcohol and tobacco also play a role in the development of foot ulcers.
Ulcers form due to a combination of factors, such as lack of feeling in the foot, poor circulation, foot deformities, irritation (such as friction or pressure), and trauma, as well as the duration of diabetes. Patients who have diabetes for many years can develop neuropathy, a reduced or complete lack of ability to feel pain in the feet due to nerve damage caused by elevated blood glucose levels over time. The nerve damage often can occur without pain, and one may not even be aware of the problem. Your podiatrist can test feet for neuropathy with a simple, painless tool called a monofilament.
Vascular disease can complicate a foot ulcer, reducing the body's ability to heal and increasing the risk for an infection. Elevations in blood glucose can reduce the body's ability to fight off a potential infection and also slow healing.
REGRANEX gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply when used as an adjunct to, and not a substitute for, good ulcer care practices.
The efficacy of REGRANEX gel has not been established for the treatment of pressure ulcers and venous stasis ulcers.
The effects of REGRANEX gel on exposed joints, tendons, ligaments, and bone have not been established in humans.
REGRANEX gel is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that close by primary intention.
Malignancies distant from the site of application have been reported in both a clinical study and in postmarketing use. The benefits and risks of REGRANEX gel treatment should be carefully evaluated before prescribing in patients with known malignancy.