Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort
1 other identifier
interventional
81
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2013
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 2, 2013
CompletedFirst Posted
Study publicly available on registry
December 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
December 15, 2016
CompletedDecember 15, 2016
October 1, 2016
1.7 years
December 2, 2013
July 12, 2016
October 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30 days
Study Arms (2)
ACTitouch
EXPERIMENTALACTitouch 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
ACTIVE COMPARATORStandard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
Interventions
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.
Eligibility Criteria
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%
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tactile Medicallead
Study Sites (11)
Associated Foot and Ankle Specialists, LLC
Phoenix, Arizona, 85015, United States
Empire Orthopedic Center
Colton, California, 92324, United States
University of California, San Diego
La Jolla, California, 92093, United States
VA Loma Linda Healthcare System
Loma Linda, California, 92357, United States
Long Beach VA Healthcare System
Long Beach, California, 90822, United States
Park Nicollet Heart and Vascular Center
Minneapolis, Minnesota, 55426, United States
Stony Brook Vein Center
Stony Brook, New York, 11794-8191, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106-1261, United States
Ohio Health System
Columbus, Ohio, 43214, United States
Jobst Vascular Institute
Toledo, Ohio, 43606, United States
Greenville Hospital System
Greenville, South Carolina, 29615, United States
Related Publications (1)
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.
PMID: 28818225DERIVED
Limitations and Caveats
Participants could have either unilateral or bilateral disease. Bilateral participants had treatment randomly assigned to the right leg. The left leg received the treatment not assigned to their right leg (i.e: right leg - Grp A: Left Leg - Grp B).
Results Point of Contact
- Title
- Director of Clinical Research
- Organization
- Tactile Medical
Study Officials
- PRINCIPAL INVESTIGATOR
Fedor Lurie, MD, PhD
Associate Director, Jobst Vascular Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2013
First Posted
December 19, 2013
Study Start
November 1, 2013
Primary Completion
July 1, 2015
Study Completion
August 1, 2015
Last Updated
December 15, 2016
Results First Posted
December 15, 2016
Record last verified: 2016-10