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

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ClinicalTrials.gov Identifier: NCT02015221
Recruitment Status : Completed
First Posted : December 19, 2013
Results First Posted : December 15, 2016
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
Tactile Medical

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Venous Insufficiency Device: Dual Action Pneumatic Compression Device Device: Standard Compression Garments Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort
Study Start Date : November 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: 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.
Active Comparator: Standard Compression Garments
Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
 Device: Standard Compression Garments
Compression stockings with a 30-40mmHg level of compression.


Outcome Measures
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Primary Outcome Measures :
  1. Ease of Use and Comfort for Subjects Using the ACTitouch System. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015221


Locations
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United States, Arizona
Associated Foot and Ankle Specialists, LLC
Phoenix, Arizona, United States, 85015
United States, California
Empire Orthopedic Center
Colton, California, United States, 92324
University of California, San Diego
La Jolla, California, United States, 92093
VA Loma Linda Healthcare System
Loma Linda, California, United States, 92357
Long Beach VA Healthcare System
Long Beach, California, United States, 90822
United States, Minnesota
Park Nicollet Heart and Vascular Center
Minneapolis, Minnesota, United States, 55426
United States, New York
Stony Brook Vein Center
Stony Brook, New York, United States, 11794-8191
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106-1261
Ohio Health System
Columbus, Ohio, United States, 43214
Jobst Vascular Institute
Toledo, Ohio, United States, 43606
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Tactile Medical
Investigators
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Principal Investigator: Fedor Lurie, MD, PhD Associate Director, Jobst Vascular Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tactile Medical
ClinicalTrials.gov Identifier: NCT02015221    
Other Study ID Numbers: ACTitouch EOU
First Posted: December 19, 2013    Key Record Dates
Results First Posted: December 15, 2016
Last Update Posted: December 15, 2016
Last Verified: October 2016
Keywords provided by Tactile Medical:
chronic venous insufficiency
venous leg ulcers
pneumatic compression
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases