Back to resultsCost Evaluation of Venous Leg Ulcers Management (EPIC)
Primary Purpose
Varicose Ulcer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Profore
Coban2
Sponsored by
About this trial
This is an interventional health services research trial for Varicose Ulcer focused on measuring Costs and Cost Analysis, Humans, Health Care Costs, varicose ulcer, Compression Bandages
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
Sites / Locations
- Quimper Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Compression1
Compression2
Arm Description
Multilayer compression bandage (Profore)
Coban2 compression system
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Prevalence of adverse events related to compression
Number and type of adverse events related to compression bandages
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
Number of patients with fully healed ulcer
Full healing rate
EuroQoL 5D-5L change between baseline and last visit
Quality of Life
Average time to full healing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02728986
Brief Title
Cost Evaluation of Venous Leg Ulcers Management
Acronym
EPIC
Official Title
Comparative and Prospective Evaluation of Direct Cost of Venous Leg Ulcers Management With Two Compression Systems
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 17, 2015 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Ulcer
Keywords
Costs and Cost Analysis, Humans, Health Care Costs, varicose ulcer, Compression Bandages
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Compression1
Arm Type
Active Comparator
Arm Description
Multilayer compression bandage (Profore)
Arm Title
Compression2
Arm Type
Experimental
Arm Description
Coban2 compression system
Intervention Type
Device
Intervention Name(s)
Profore
Intervention Description
Profore multilayer compression bandage + standard regimen for wound care according to investigator's choice
Intervention Type
Device
Intervention Name(s)
Coban2
Intervention Description
Coban2 compression system + standard regimen for wound care according to investigator's choice
Primary Outcome Measure Information:
Title
Direct cost of leg ulcer management
Description
Direct cost includes cost of bandages, dressings, nurse/doctor visits. Cost will be computed upon consumptions reported by healthcare professionals.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Prevalence of adverse events related to compression
Description
Number and type of adverse events related to compression bandages
Time Frame
16 weeks
Title
Patient's compression bandage acceptance score
Description
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
Title
Number of patients with fully healed ulcer
Description
Full healing rate
Time Frame
16 weeks
Title
EuroQoL 5D-5L change between baseline and last visit
Description
Quality of Life
Time Frame
16 weeks
Title
Average time to full healing
Time Frame
16 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie Meaume, MD
Organizational Affiliation
AP-HP Hôpital Rothschild - Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Quimper Center
City
Quimper
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Cost Evaluation of Venous Leg Ulcers Management
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