The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4 weeks of treatment using a dual action pneumatic compression device.
Subjects with a chronic venous leg ulcer will participate in a 2 week run in phase using standard of care multi-layer bandaging before receiving 4 weeks of treatment using a pneumatic compression device. Subjects will be seen in clinic weekly for an evaluation, complete symptom and quality of life questionnaires.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period.
Center for Clinical Research
San Francisco, California, United States
University of Miami School Hospital
Miami, Florida, United States
Tufts Medical Center
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device
A questionnaire that was completed after receiving four weeks of treatment from a dual action pneumatic compression device. Questions listed below: 1. The device was comfortable to wear during Sustained Compression Mode. 2. The device was comfortable to wear during Intermittent Compression Mode. 3. The noise from the device was not bothersome. 4. The device was easy to put on. 5. The device was easy to take off. 6. The device was easy to use. 7. The device was light-weight and portable. 8. The use of the device helped my wound heal faster. 9. I would use the device again on another wound in the future. 10. Since using the device, my quality of sleep has improved. 11. It was a burden to come to the wound care clinic for my dressing changes. 12. The use of the device did not restrict many of my normal activities. 13. The device was cumbersome and interfered with my mobility. 14. I was able to work while being treated with the device.
Time frame: 4 weeks
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Englewood Hospital and Medical Center
Englewood, New Jersey, United States
St. Luke's Roosevelt Hospital Center
New York, New York, United States