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Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)

NCT02395302 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-03-27

Study results available
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Summary

The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4 weeks of treatment using a dual action pneumatic compression device.

Conditions

  • Venous Leg Ulcer
  • Chronic Venous Insufficiency
  • Venous Stasis Ulcer
  • Venous Ulcer
  • Venous Insufficiency

Interventions

DEVICE

Dual Action Pneumatic Compression

Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period.

Sponsors & Collaborators

  • Tactile Medical

    lead INDUSTRY

Principal Investigators

  • William Marston, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-09-30
Completion
2015-11-30

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 NCT02395302 on ClinicalTrials.gov