A pilot study of venous flow augmentation using a novel mechanical graded intermittent sequential compression device for venous insufficiency

Background: Guidelines as well as multiple RTCs support the use of intermittent pneumatic compression (IPC) for the treatment of venous leg ulcers when conservative measures fail. Unfortunately, the clinical usefulness of IPC is significantly limited by the physical limitations of pneumatic motors, which leads to bulky devices with slow inflation cycles, uncomfortable sleeves, lack of patient mobility, and ultimately poor patient compliance with therapy. A novel mechanical device for lower leg graded intermittent sequential compression was designed to address these limitations of IPC therapy for venous leg ulcer treatment by providing rapid compression cycles in a truly wearable device that offers the additional benefit of monitoring compression dose and patient compliance. The wearable intermittent compression (WIC) device was hypothesized to provide improved augmentation of venous flow compared with both baseline and standard IPC therapy. Methods: Ten patients with Clinical, Etiologic, Anatomic and Pathophysiologic class 3 to 6 venous insufficiency were recruited under institutional review board approval. The primary end point for the study was augmentation of venous blood flow as measured by peak venous velocity. Patients underwent measurement of peak venous velocity in centimeters per second at the popliteal and femoral veins for the following conditions: (1) baseline, (2) WIC device on a low setting, and (3) WIC device on a high setting. In five patients, an additional measurement of peak venous velocity in centimeters per second at the popliteal and femoral veins was completed while wearing a commercially available IPC device. Results: Both low and high settings of the WIC device resulted in higher average peak venous velocities when compared with both baseline and the IPC device (P < .05). No patients reported discomfort with either the WIC device or the IPC device during therapy. Conclusions: The WIC device significantly increases the augmentation of venous flow as measured by peak venous velocity in both the popliteal and femoral veins in patients with Clinical, Etiologic, Anatomic and Pathophysiologic class 3 to 6 venous insufficiency. In addition, the WIC device was found to be easy to use and comfortable during therapy. Future studies are planned to determine if the WIC improvements in venous flow augmentation and patient compliance will lead to higher rates of venous ulcer healing.