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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗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.
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