Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort

Completed · Not applicable

Conditions studied: Chronic Venous Insufficiency

In brief

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.

Key facts

Study ID

NCT02015221

Run by

Tactile Medical

People needed

81

Starts

2013-11-01

Expected to finish

2015-08-01

Last updated by the study team

2016-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of unilateral or bilateral CVI with or without leg ulcers
• Documented history of low adherence to compression garment therapy
• CEAP classification C3-C6
• Leg circumferences within the following ranges: Ankle 12-44cm, calf 22-6m, below the knee 22-68cm

You may not qualify if…

• History of skin sensitivity to any of the components of ACTitouch or compression garments
• History of acute (deep vein thrombosis) DVT or (pulmonary embolism) PE within the last 3 months
• Ankle Brachial Index (ABI) < 0.8
• Acute thrombophlebitis
• History of pulmonary edema or decompensated congestive heart failure
• Currently has an active infection of the skin such as cellulitis requiring antibiotics
• Poorly controlled diabetes with an HbA1c value of >10%
• Exhibits any condition which, according to the PI, justifies the subjects exclusion from the study, such as a medical condition where an increase in venous or lymphatic return is undesirable.
• Subjects with open ulcers must be able to follow their care regimen for ulcer healing concurrently with the assigned study regimen.
• Participating in another clinical trial
• Changes to medications that affect edema within the last 30 days
• Currently pregnant or trying to become pregnant

Where it is running

• 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
• VA Loma Linda Healthcare System — Loma Linda, California, United States
• Long Beach VA Healthcare System — Long Beach, California, United States
• Park Nicollet Heart and Vascular Center — Minneapolis, Minnesota, United States
• Stony Brook Vein Center — Stony Brook, New York, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Ohio Health System — Columbus, Ohio, United States
• Jobst Vascular Institute — Toledo, Ohio, United States
• Greenville Hospital System — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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