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

Not Applicable

Completed

Interventions: Device: Dual Action Pneumatic Compression Device
Device: Standard Compression Garments

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
ACTitouch	Dual Action Pneumatic Compression Device	ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.
Standard Compression Garments	Standard Compression Garments	Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.

Primary Outcome Measures

Name	Time	Method
Ease of Use and Comfort for Subjects Using the ACTitouch System.	30 days	Ease of application and removal (donning and doffing) the treatment at the baseline visit. Comfort of treatment after the treatment was first applied.

Secondary Outcome Measures

Name	Time	Method

Locations (11): Empire Orthopedic Center
🇺🇸
Colton, California, United States
Long Beach VA Healthcare System
🇺🇸
Long Beach, California, United States
Jobst Vascular Institute
🇺🇸
Toledo, Ohio, United States
Associated Foot and Ankle Specialists, LLC
🇺🇸
Phoenix, Arizona, 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
VA Loma Linda Healthcare System
🇺🇸
Loma Linda, California, United States
Greenville Hospital System
🇺🇸
Greenville, South Carolina, United States
Park Nicollet Heart and Vascular Center
🇺🇸
Minneapolis, Minnesota, United States
University of California, San Diego
🇺🇸
La Jolla, California, United States