Varicose Ulcer
Conditions
Keywords
Costs and Cost Analysis, Humans, Health Care Costs, varicose ulcer, Compression Bandages
Brief summary
The purpose of this study is to evaluate direct costs of Venous Leg Ulcers (VLU) management when two different compression systems are used.
Detailed description
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.
Interventions
DEVICEProfore
Profore multilayer compression bandage + standard regimen for wound care according to investigator's choice
DEVICECoban2
Coban2 compression system + standard regimen for wound care according to investigator's choice
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* consent to participate * ambulatory management * 1 to 3 leg ulcers * leg ulcers below the knee and above ankle * no contra-indication to wear compression bandage * not currently treated by one of the investigational devices
Exclusion criteria
* cognitive impairment * opposition to wear compression bandage * bedridden * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Direct cost of leg ulcer management | 16 weeks | Direct cost includes cost of bandages, dressings, nurse/doctor visits. Cost will be computed upon consumptions reported by healthcare professionals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of adverse events related to compression | 16 weeks | Number and type of adverse events related to compression bandages |
| Patient's compression bandage acceptance score | 16 weeks | Four ad hoc 7-level Likert scales will be used to assess bandage impact on daily activities, sleep, shoes and slippage |
| Number of patients with fully healed ulcer | 16 weeks | Full healing rate |
| EuroQoL 5D-5L change between baseline and last visit | 16 weeks | Quality of Life |
| Average time to full healing | 16 weeks | — |
Countries
France
Outcome results
None listed