Critical limb ischemia (CLI), a manifestation of peripheral arterial disease, is a debilitating and increasingly common disease that puts patients at a high risk for leg amputation, cardiovascular complications, and death. A new report in the Journal of Vascular Surgery chronicles a multi-site randomized controlled trial that seeks to compare treatment efficacy, functional outcomes, cost effectiveness, and quality of life for 2,100 patients suffering from the condition.

"The BEST-CLI Trial is Nearing the Finish Line and Promises to be Worth the Wait," is authored by Alik Farber, MD, chief of vascular and endovascular surgery at Boston Medical Center, Matthew Menard, MD, co-director of endovascular surgery at Brigham and Women's Hospital, Kenneth Rosenfield, MD, section head for vascular medicine and intervention at Massachusetts General Hospital, and Flora Sandra Siami, MPH, vice president, clinical, regulatory, quality at the New England Research Institutes. Farber, Rosenfield, Siami, and Menard are Principal Investigators of the trial.

Critical limb ischemia, also known as chronic limb-threatening ischemia, is a condition in which there is insufficient blood flow to an extremity, such as an arm or leg, to allow for normal metabolic function. As the population ages and the incidence of diabetes, obesity and chronic kidney disease increases, so will the incidence of peripheral arterial disease and, consequently, CLI. A study published in 2011 found that insufficient management of CLI is responsible for substantial healthcare and societal costs - and these figures continue to increase nationally.

Globally recognized vascular medicine specialist and President of Newton-Wellesley Hospital Michael R. Jaff, DO, considers the BEST-CLI Trial to be "...the most important, impactful, patient-centered clinical trial of critical limb ischemia of my professional lifetime."

With 134 active enrollment sites and new sites being added, including sites in Europe and New Zealand, BEST-CLI has become an international effort. It has encountered a number of obstacles, but they are successfully being navigated.

"Perhaps the most difficult barrier we've encountered in getting patients enrolled in the study is that of treatment bias," said Farber, of Boston Medical Center. "Despite widespread agreement that an evidence-based standard of care is lacking in patients with the condition, most physicians hold individual biases with regard to whether open or endovascular revascularization strategy is best for any given patient."

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