Clinical trial NCT02015221: Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort
Official title: Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Venous Insufficiency
Keywords: chronic venous insufficiency
venous leg ulcers
pneumatic compression
Lead sponsor: Tactile Medical
Sponsor class: INDUSTRY
First posted: 2013-12-19
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: Ease of Use and Comfort for Subjects Using the ACTitouch System.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Associated Foot and Ankle Specialists, LLC
state: Arizona
city: Colton
country: United States
facility: Empire Orthopedic Center
state: California
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System
state: California
city: Long Beach
country: United States
facility: Long Beach VA Healthcare System
state: California
city: Minneapolis
country: United States
facility: Park Nicollet Heart and Vascular Center
state: Minnesota
city: Stony Brook
country: United States
facility: Stony Brook Vein Center
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio Health System
state: Ohio
city: Toledo
country: United States
facility: Jobst Vascular Institute
state: Ohio
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
Study officials:
affiliation: Associate Director, Jobst Vascular Institute
name: Fedor Lurie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.