The purpose of this study is to evaluate direct costs of Venous Leg Ulcers (VLU) management when two different compression systems are used.
The purpose of this study is to evaluate direct costs of Venous Leg Ulcers management when two different compression systems are used. Micro-costing during the study will bring direct costs which include nurse and physician time, dressings and bandages. Perspective of costs will be Public Health Insurance. Time horizon will be 16 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
176
Quimper Center
Quimper, France
Direct cost of leg ulcer management
Direct cost includes cost of bandages, dressings, nurse/doctor visits. Cost will be computed upon consumptions reported by healthcare professionals.
Time frame: 16 weeks
Prevalence of adverse events related to compression
Number and type of adverse events related to compression bandages
Time frame: 16 weeks
Patient's compression bandage acceptance score
Four ad hoc 7-level Likert scales will be used to assess bandage impact on daily activities, sleep, shoes and slippage
Time frame: 16 weeks
Number of patients with fully healed ulcer
Full healing rate
Time frame: 16 weeks
EuroQoL 5D-5L change between baseline and last visit
Quality of Life
Time frame: 16 weeks
Average time to full healing
Time frame: 16 weeks
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