Cost Evaluation of Venous Leg Ulcers Management

Study Overview
=================
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.

Official Title
-----------------
Comparative and Prospective Evaluation of Direct Cost of Venous Leg Ulcers Management With Two Compression Systems

Conditions
-----------------
Varicose Ulcer

Intervention / Treatment
-----------------
* Device: Profore
* Device: Coban2


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Compression1<br>Multilayer compression bandage (Profore) | Device: Profore<br>* Profore multilayer compression bandage + standard regimen for wound care according to investigator's choice<br>|
| Experimental: Compression2<br>Coban2 compression system | Device: Coban2<br>* Coban2 compression system + standard regimen for wound care according to investigator's choice<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of adverse events related to compression | Number and type of adverse events related to compression bandages | 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 | 16 weeks | 
| Number of patients with fully healed ulcer | Full healing rate | 16 weeks | 
| EuroQoL 5D-5L change between baseline and last visit | Quality of Life | 16 weeks | 
| Average time to full healing |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Costs and Cost Analysis, Humans, Health Care Costs, varicose ulcer, Compression Bandages