Saint Luke’s offers trial to evaluate safety and effectiveness of treatment for critical limb ischemia

December 21, 2011

KANSAS CITY, Mo. (Dec. 21, 2011) Patients suffering from life-threatening critical limb ischemia (CLI) who can't be treated with conventional surgery or stents may be eligible to enroll in a clinical trial available at Saint Luke's Hospital. Research is underway with the enrollment of patients to study a potential treatment that might help to avoid amputation.

Critical limb ischemia - a lack of adequate blood flow to the leg or foot - is a serious, life-threatening condition with more than one in five patients dying in the first year of diagnosis, and nearly half of all CLI patients needing surgery to preserve their limbs. Few treatment options exist.

In some patients, CLI can be managed with surgical options to increase blood flow," said Saint Luke's vascular surgeon Keith Allen, M.D., principal investigator. "However some patients aren't good candidates for surgery because of prior operations or poor quality of the arteries in the leg. Many of these patients develop wounds that won't heal because of poor circulation and in some the only treatment is amputation. The REVIVE study is a potential option for those patients."

REVIVE is a clinical trial designed to evaluate the safety and effectiveness of injecting cells obtained from the patient's own blood or bone marrow into the leg with poor circulation. The goal of this study is to test whether this process might stimulate new blood vessel growth, called angiogenesis. Patients who qualify for the study will have a one in two chance of actually receiving the stem cells. Half of enrolled patients will receive a placebo injection instead, with no stem cells, so that outcomes between the groups can be compared. Trial participation lasts about 18 months.

For more information about the study at Saint Luke's, call 816-932-4828.