Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada
Original Research Article
Venous Return Assist Devices for Intermittent Claudication: A Randomized Controlled Trial Utilizing a Sham Comparator
Author(s): François Caron, Ankit Garg, Eric Kaplovitch, Natasha Aleksova, Barbara Nowacki, Russell de Souza, Binod Neupane, Jeff Ginsberg, Jack Hirsh, John Eikelboom and Sonia S Anand*
Objectives: To determine whether an intermittent mechanical compression device (Venowave) effects walking distance in patients with intermittent claudication as compared to placebo, as well as to review the published literature on the topic. Design: Randomized, cross-over, blinded trial of an intermittent mechanical compression device (Venowave), compared with a sham compression device. Setting: Hamilton Health Sciences, Hamilton, Canada. Participants: 27 patients with severe peripheral limb ischemia, as identified by at least one of: i) ABI<0.4; ii) ACD<200 m (Fontaine stage IIb); iii) toe-brachial index<0.5; or iv) toe pressure<40 mmHg or rest pain due to arterial ischemia. Main Outcome Measures: The primary outcome measure was Absolute Claudication Distance (ACD) while walking on a treadmill. Secondary outcome measures included Initial Claudication Distance (ICD), walk .. View more»