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VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging

NCT02680834 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-02-19

Study results available
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Summary

The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.

Conditions

  • Venous Leg Ulcer

Interventions

DEVICE

Dual Action Pneumatic Compression Device

Dual action pneumatic compression device used to treat chronic VLUs.

DEVICE

Multi-Layer Bandaging

Multi-layer bandaging used to treated chronic VLUs

Sponsors & Collaborators

  • Tactile Medical

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-05-31
Completion
2017-06-30

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 NCT02680834 on ClinicalTrials.gov