Flexitouch Compression System for Venous Stasis Ulcer
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|ClinicalTrials.gov Identifier: NCT00534937|
Recruitment Status : Terminated (Ineffective Recruitment (Business Decision))
First Posted : September 26, 2007
Results First Posted : March 1, 2013
Last Update Posted : March 1, 2013
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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Venous Stasis Ulcer||Procedure: Compression wrapping Procedure: Flexitouch compression pump||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial of the Flexitouch Compression System as an Adjunctive Treatment for Venous Stasis Ulcer|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||December 2010|
Active Comparator: Standard compression
Patients in this arm will receive current standard of care (once-weekly short-stretch compression wrapping).
Procedure: Compression wrapping
Short-stretch compression wrap will be applied at least once a week.
Other Name: 3M short-stretch compression wrap
Patients in this arm will receive once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
Procedure: Flexitouch compression pump
In addition to short-stretch wrapping, this group will received once-daily Flexitouch compression pump, both at home and during the once-a-week clinic visits.
Other Name: 3M compression wrap
- Complete Healing Rate of Venous Stasis Ulcers [ Time Frame: 12 weeks ]Number of subjects that experience complete healing of the study venous stasis ulcer during the 12 week treatment period.
- Change in Wound Surface Area for Non Healed Subject at 12 Weeks. [ Time Frame: 12 weeks ]Change in wound surface area in cm2 from the initial screening to week 12 for all subject who did not completely healed before or at the 12 week visit.
- Percentage Change in Volume of the Affected Limb (-Reduction; +Increase) [ Time Frame: 12 weeks ]
- Time to Healing of the Venous Stasis Ulcer [ Time Frame: Baseline to 12 weeks ]Only 2 time points so no calculation details are necessary. The change is calculated as the later time point minus the earlier time point (e.g., 12 weeks minus baseline).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534937
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Allegheny General Hospital Advanced Wound Healing and Lymphedema Center|
|Pittsburgh, Pennsylvania, United States, 15212|
|Principal Investigator:||Satish Muluk, MD||West Penn Allegheny Health System|