The purpose of this study is to determine the ease of use and comfort of the ACTitouch dual action pneumatic compression device in patients with unilateral or bilateral chronic venous insufficiency (CVI) with or without venous leg ulcers, as compared to standard compression.
Subjects will be randomized to receive either the ACTitouch system or standard compression garments, and will respond to symptom surveys and quality of life surveys to assess comfort and ease of use of each. These will be conducted at Baseline, at Day 15 and Day 30.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
81
A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
Compression stockings with a 30-40mmHg level of compression.
Associated Foot and Ankle Specialists, LLC
Phoenix, Arizona, United States
Empire Orthopedic Center
Colton, California, United States
University of California, San Diego
La Jolla, California, United States
Ease of Use and Comfort for Subjects Using the ACTitouch System.
Ease of application and removal (donning and doffing) the treatment at the baseline visit. Comfort of treatment after the treatment was first applied.
Time frame: 30 days
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...and 1 more locations