Flexitouch Compression System for Venous Stasis Ulcer
Public ClinicalTrials.gov record NCT00534937. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Trial of the Flexitouch Compression System as an Adjunctive Treatment for Venous Stasis Ulcer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00534937
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 89 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2007
- Primary completion
- Jun 30, 2010
- Completion
- Nov 30, 2010
- Last update posted
- Feb 28, 2013
2007 – 2010
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Allegheny General Hospital Advanced Wound Healing and Lymphedema Center | Pittsburgh | Pennsylvania | 15212 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00534937, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 28, 2013 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00534937 live on ClinicalTrials.gov.