Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort
NCT ID: NCT02015221
Last Updated: 2016-12-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2013-11-30
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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ACTitouch
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.
Dual Action Pneumatic Compression Device
A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
Standard Compression Garments
Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
Standard Compression Garments
Compression stockings with a 30-40mmHg level of compression.
Interventions
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Dual Action Pneumatic Compression Device
A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
Standard Compression Garments
Compression stockings with a 30-40mmHg level of compression.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Tactile Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Fedor Lurie, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Associate Director, Jobst Vascular Institute
Locations
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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
Countries
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References
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Lurie F, Schwartz M. Patient-centered outcomes of a dual action pneumatic compression device in comparison to compression stockings for patients with chronic venous disease. J Vasc Surg Venous Lymphat Disord. 2017 Sep;5(5):699-706.e1. doi: 10.1016/j.jvsv.2017.06.003.
Other Identifiers
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ACTitouch EOU
Identifier Type: -
Identifier Source: org_study_id