How is critical limb ischemia (CLI) treated?

The best way to treat Critical Limb Ischemia (CLI) is to restore the blood flow through the arteries in the leg below the knee all the way down to the feet and toes. This is known as revascularization.

There are two main types of revascularization:

    During an endovascular procedure a thin line is inserted into an artery in the groin or arm, from where the obstructed blood vessel is entered. At the position where the vessel is narrowed, a balloon is inflated and presses the fatty deposits against the wall to widen the vessel.
    Additionally, a small, expandable tube called a stent could be inserted to keep the vessel open.
    Devices may also be used to remove the fatty deposits from the blocked artery.
    During a surgical procedure, the surgeon can make a new connection between blood vessels in your leg around the narrowed blood vessel, to try and improve the blood flow to the calf, foot and toes.

Unfortunately, for many patients with diabetes and critical limb ischemia, it is not possible to use an endovascular or surgical procedure because the blood vessels are in a very poor state or the condition of the patient does not allow for these types of procedures. Furthermore, in many cases, neither the endovascular or surgical procedure works sufficiently.

Often, the only remaining option is amputation of the foot or even the leg below the knee. For these patients, novel investigational therapies, such as cell therapy (like the REX-001 study treatment) may be an alternative treatment that could improve the blood flow in the leg.