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Flexitouch Treatment for Venous Ulcers

NCT00847002 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-02-12

Study results available
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Summary

This is a study to compare the healing process of venous stasis ulcers when the Flexitouch® system is added to the standard treatment of venous ulcers. We hypothesize that adding the Flexitouch® system to standard venous ulcer treatment will result in

1. greater complete healing
2. greater percentage reduction in ulcer area
3. reduced time to complete healing, as compared to the use of standard treatment alone
4. a greater reduction in affected leg volume as compared to standard treatment alone.

Conditions

  • Venous Ulcer

Interventions

DEVICE

Standard Wound Care

DEVICE

Flexitouch System with Standard Wound Care

Sponsors & Collaborators

  • Tactile Systems Technology, Inc.

    lead INDUSTRY

Principal Investigators

  • Wade Farrow, MD · Wound Healing and Hyperbaric Center

  • Sunday Hoy, JD · Tactile Systems Techonology Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-08-31
Completion
2010-08-31
FDA Device
Yes

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 NCT00847002 on ClinicalTrials.gov