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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Venous Insufficiency
• Intervention / Treatment: Device: Dual Action Pneumatic Compression Device; Device: Standard Compression Garments

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Associated Foot and Ankle Specialists, LLC
  • California
    • Colton, California, United States, 92324
      • Empire Orthopedic Center
    • La Jolla, California, United States, 92093
      • University of California, San Diego
    • Loma Linda, California, United States, 92357
      • VA Loma Linda Healthcare System
    • Long Beach, California, United States, 90822
      • Long Beach VA Healthcare System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55426
      • Park Nicollet Heart and Vascular Center
  • New York
    • Stony Brook, New York, United States, 11794-8191
      • Stony Brook Vein Center
  • Ohio
    • Cleveland, Ohio, United States, 44106-1261
      • University Hospitals Case Medical Center
    • Columbus, Ohio, United States, 43214
      • Ohio Health System
    • Toledo, Ohio, United States, 43606
      • Jobst Vascular Institute
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Greenville Hospital System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tactile Medical
• Investigators: Principal Investigator: Fedor Lurie, MD, PhD, Associate Director, Jobst Vascular Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: December 2, 2013
• First Submitted That Met QC Criteria: December 12, 2013
• First Posted (ESTIMATE): December 19, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 15, 2016
• Last Update Submitted That Met QC Criteria: October 21, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: venous leg ulcers; chronic venous insufficiency; pneumatic compression
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: ACTitouch EOU