In Critical Limb Ischemia (CLI), fatty deposits block arteries in the leg, leading to greatly reduced blood flow. This causes leg pain at rest, non-healing ulcers and gangrene. Patients with CLI are at an immediate risk for limb amputation and death. It is estimated that there are two million people in the United States with CLI, and this number is projected to grow to almost 2.8 million by 2020. In Western Europe, 3 million people have CLI. Reflecting the ageing population, and the increasing rate of diabetes, this number is projected to grow to 4 million by 2030.
While some non-surgical treatments exist to relieve pain and provide local ulcer care, most patients will ultimately need revascularization with vascular bypass surgery or an endovascular procedure to try to prevent a major limb amputation and prolong survival. Many patients, however, are not suitable candidates for revascularization, and have amputation rates of up to 39% at 6 months from diagnosis.
In view of the lack of suitable therapeutic options for the growing population of CLI patients, new approaches are warranted in order to reduce the number of amputations and their impact on quality of life and on life expectancy.