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

NCT02015221 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2016-12-15

Study results available
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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.

Conditions

  • Chronic Venous Insufficiency

Interventions

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.

DEVICE

Standard Compression Garments

Compression stockings with a 30-40mmHg level of compression.

Sponsors & Collaborators

  • Tactile Medical

    lead INDUSTRY

Principal Investigators

  • Fedor Lurie, MD, PhD · Associate Director, Jobst Vascular Institute

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-07-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02015221 on ClinicalTrials.gov