The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.
Participants with a chronic venous leg ulcer will participate in a 2 week run in phase using standard of care multi-layer bandaging before being randomly assigned to either treatment using a dual action pneumatic compression device or continued multi-layer bandaging for up to 16 weeks. Participants will be seen in clinic for treatment and evaluation of symptoms and quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Dual action pneumatic compression device used to treat chronic VLUs.
Multi-layer bandaging used to treated chronic VLUs
Phoenix VA Health Care System
Phoenix, Arizona, United States
Associated Foot and Ankle Specialists, LLC
Phoenix, Arizona, United States
Percentage of VLU Area Reduction
Percentage of ulcer area reduction in the target VLU during the 16 week treatment period calculated by wound imaging software.
Time frame: Changes from Baseline to 16 weeks
Patient-Reported Quality of Life
The Charing Cross Venous Ulcer Questionnaire assesses the patients' perception of their health when venous ulceration is present. All items are scored so that a lower score defines a more favorable health state (a greater reduction is associated with improved quality of life). In addition, each item is scored using a 1 to 5 range so that the lowest and highest possible scores are 0 and 100, respectively.
Time frame: Changes from Baseline to 16 weeks
Outpatient Costs
Assessment of the effect of the Actitouch compared to a standard regimen of multi-layer bandaging on mean total outpatient costs per subject.
Time frame: Changes from Baseline to 16 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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