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NCT00534937 · ClinicalTrials.gov registry record · Phase 4

Flexitouch Compression System for Venous Stasis Ulcer

A Phase 4 study, sponsored by West Penn Allegheny Health System.

Terminated
Registry status
Phase 4
Development phase
89
Enrollment target

NCT00534937 is a Phase 4 study that was terminated before completion, run by West Penn Allegheny Health System. The registered enrollment target is 89 participants.

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The verdict

NCT00534937, a Phase 4 study, was terminated before completion, sponsored by West Penn Allegheny Health System.

TERMINATED
Registry status
Phase 4
Development phase
89 participants
Enrollment target

Study 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.

Interventions

  • PROCEDURE Compression wrapping
  • PROCEDURE Flexitouch compression pump

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2007-09
Est. Completion 2010-12
Phase Phase 4

Sponsor

West Penn Allegheny Health System

14 total trials

What the Registry Record Tells You About NCT00534937

The ClinicalTrials.gov registry entry for NCT00534937 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is West Penn Allegheny Health System, which has 14 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Compression wrapping is the first listed.

NCT00534937 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00534937 about?

NCT00534937 is a clinical study titled "Flexitouch Compression System for Venous Stasis Ulcer". 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 s...

What is the current status of trial NCT00534937?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 89 participants. The study started on 2007-09. Estimated completion is 2010-12.

What interventions are being tested in trial NCT00534937?

The interventions under investigation include: Compression wrapping (PROCEDURE), Flexitouch compression pump (PROCEDURE).

Who is sponsoring clinical trial NCT00534937?

This trial is sponsored by West Penn Allegheny Health System, which has 14 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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