Compression Device Versus 4-layer Compression System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00821431|
Recruitment Status : Completed
First Posted : January 13, 2009
Results First Posted : January 9, 2015
Last Update Posted : January 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Leg Ulcers||Device: Compression Device Device: Profore||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study to Compare the Effect of a Compression Device to That of a 4-layer Compression System on Subjects With Venous Leg Ulcers.|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
Experimental: Compression device
The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.
Device: Compression Device
Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:
Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.
Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day.
Active Comparator: Profore, 4-layer bandage
A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.
Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert.
- Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer) [ Time Frame: 12 Weeks ]
- Healing Measured by Number of Subjects Healed During the 12 Week Study Period [ Time Frame: 12 weeks ]
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): NCT00821431
|Study Director:||Jonathon Hopper, MD||ConvaTec Inc.|