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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: Clinical Trial Phase 4 study, sponsored by West Penn Allegheny Health System.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of subjects that experience complete healing of the study venous stasis ulcer during the 12 week treatment period.
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 |
Why NCT00534937 stopped before completion
NCT00534937 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Compression wrapping is the first listed.
NCT00534937 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00534937's enrollment target sits among peer trials
89 913th of 2000 higher than 1,085 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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