Intermittent Claudication (IC) is caused by fatty deposits that accumulate in the arteries of the leg and reduce blood flow. The most common symptoms are leg pain and weakness brought on by exercise, with resolution of the symptoms following rest. Risk factors include hyperlipidemia, diabetes, hypertension, sedentary lifestyle, and smoking.
In the U.S. approximately 3% of patients aged 40 years, and 6% of patients aged 60, have IC. It can progress to Critical Limb Ischemia, a more severe form of peripheral artery disease which can lead to leg amputation and death. Conservative treatment options include the control of cardiovascular risk factors, including smoking cessation, control of blood pressure and glucose level, drugs to lower cholesterol, and drugs to prevent blood clots as well as vasodilators such as cilostazole and supervised exercise. Patients not improved by conservative treatment are offered surgical or endovascular revascularization to open blocked arteries, but these invasive procedures are not always successful. PLX-PAD may present an alternative treatment option by stimulating the body to grow new arteries in the leg to bypass the blocked ones.