Advice on Foot Care

The following is a press release by the American Podiatric Medical Association

New Stem Cell Injections May Help Prevent Amputations: American Podiatric Medical Association Member Assisting in Breakthrough Clinical Trials

October 20, 2008

Bethesda, MD– Poor blood flow to the lower limbs is a health condition that many Americans with diabetes experience. But without early detection and proper treatment, amputation is often the final outcome. In fact, more than 60 percent of non-traumatic, lower limb amputations every year occur as a result of diabetes. Diabetes is considered a major risk factor for peripheral arterial disease (PAD) and critical limb ischemia (CLI) – blood flow conditions that affect the lower limbs and can lead to amputation. However, an on-going clinical research trial using adult stem cells may help to improve blood flow and heal chronic sores for millions of people with diabetes who develop these lower limb conditions.

During the procedure, adult stem cells are carefully extracted from the blood of a patient affected with CLI and injected directly into the same patient’s calf muscle. Early research shows that the stem cells work to replenish blood vessels in the lower legs – a process known as angiogenesis. Once the new blood vessels begin restoring proper blood flow, which may take several weeks after injection, many patients may begin to see and feel improvement in overall lower limb circulation, decreased pain and increased healing in any diabetic foot ulcerations present.

According to Vickie R. Driver, DPM, MS, member of the American Podiatric Medical Association (APMA), and Director of Clinical Research Foot Care, Endovascular and Vascular Services at Boston Medical Center, the treatment in the initial clinical trials seem to have positively impacted cells in the body that are affected by PAD and CLI.

“Many patients are not eligible to undergo typical surgical procedures that reestablish blood flow, or have had a procedure that was not completely successful. That’s why stem cell treatments such as this, which are minimally invasive by comparison, are so critically important to further develop,” said Dr. Driver, who is the principal investigator of the trial at Boston University Medical Center. The novel clinical trial, sponsored by Northwestern University, also has several other test sites set up nationally.

Diabetes and PAD are the leading causes of non-traumatic, lower limb amputations. PAD is caused by a build-up of plaque on the artery walls. Currently, PAD affects 8 to 12 million Americans, and one in every five people over the age of 70 has the disease. Many individuals are not aware they have PAD. If left untreated, this blockage may become severe and develop into CLI – which can lead to sores in the lower legs and feet. If treatment is ignored too long after CLI sets in, amputation of the foot or leg often becomes the only treatment option.

The clinical trials for adult stem cell treatment are currently in Phase I/IIa trials, and must pass through Phase III before receiving FDA approval for widespread use. However, adult stem cell injection research shows a lot of promise for patients battling lower limb circulatory problems.

If any of the following PAD warning signs are experienced, a podiatric physician – also known as a podiatrist – should be consulted immediately:

• Fatigue, tiredness, cramping or pain in the legs, thighs or buttocks.
• Foot or toe pain while idle that often disturbs sleep.
• Skin wounds or ulcers on the feet or toes that are slow to heal, or that do not heal for 8-12 weeks.

More information on this stem cell clinical trial.

For more on PAD and CLI, and to learn about a podiatrist’s role in managing the various conditions caused by diabetes, visit www.apma.org/diabetes.

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