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Flexitouch Compression System for Venous Stasis Ulcer

NCT00534937 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2013-03-01

Study results available
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Summary

The researchers hypothesize that utilization of the Flexitouch system will improve the healing rates of (venous stasis ulcers) VSU compared to traditional compression wrapping therapy alone.

Primary Objective: The primary study objective is to determine whether the complete healing rate of venous stasis ulcers at 12 weeks is improved by the addition of Flexitouch® System compression therapy to a standard regimen of compression wrapping.

Secondary Objectives:

* To determine whether the addition of Flexitouch System compression therapy to a standard regimen of compression wrapping increases the percentage reduction in wound surface area.
* To determine whether the addition of Flexitouch compression therapy to a standard regimen of compression wrapping increases the percentage reduction in volume of the affected limb.
* To determine whether the addition of Flexitouch compression therapy to a standard regimen of compression wrapping decreases the time to healing of the venous stasis ulcer.

Conditions

  • Venous Stasis Ulcer

Interventions

PROCEDURE

Compression wrapping

Short-stretch compression wrap will be applied at least once a week.

PROCEDURE

Flexitouch compression pump

In addition to short-stretch wrapping, this group will received once-daily Flexitouch compression pump, both at home and during the once-a-week clinic visits.

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Tactile Systems Technology, Inc.

    collaborator INDUSTRY

  • West Penn Allegheny Health System

    lead OTHER

Principal Investigators

  • Satish Muluk, MD · West Penn Allegheny Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-07-31
Completion
2010-12-31

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 NCT00534937 on ClinicalTrials.gov