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Cost Evaluation of Venous Leg Ulcers Management (EPIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728986
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
3M

Study Description
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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.

Condition or disease Intervention/treatment Phase
Varicose Ulcer Device: Profore Device: Coban2 Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comparative and Prospective Evaluation of Direct Cost of Venous Leg Ulcers Management With Two Compression Systems
Actual Study Start Date : December 17, 2015
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : July 1, 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Compression1
Multilayer compression bandage (Profore)
 Device: Profore
Profore multilayer compression bandage + standard regimen for wound care according to investigator's choice
Experimental: Compression2
Coban2 compression system
 Device: Coban2
Coban2 compression system + standard regimen for wound care according to investigator's choice


Outcome Measures
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Primary Outcome Measures :
  1. Direct cost of leg ulcer management [ Time Frame: 16 weeks ]
    Direct cost includes cost of bandages, dressings, nurse/doctor visits. Cost will be computed upon consumptions reported by healthcare professionals.


Secondary Outcome Measures :
  1. Prevalence of adverse events related to compression [ Time Frame: 16 weeks ]
    Number and type of adverse events related to compression bandages

  2. Patient's compression bandage acceptance score [ Time Frame: 16 weeks ]
    Four ad hoc 7-level Likert scales will be used to assess bandage impact on daily activities, sleep, shoes and slippage

  3. Number of patients with fully healed ulcer [ Time Frame: 16 weeks ]
    Full healing rate

  4. EuroQoL 5D-5L change between baseline and last visit [ Time Frame: 16 weeks ]
    Quality of Life

  5. Average time to full healing [ Time Frame: 16 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728986


Locations
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France
Quimper Center
Quimper, France
Sponsors and Collaborators
3M
Investigators
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Study Chair: Sylvie Meaume, MD AP-HP Hôpital Rothschild - Paris
More Information
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Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT02728986    
Other Study ID Numbers: FR Study No-05-000001
2014-A01128-39 ( Other Identifier: ANSM )
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by 3M:
Costs and Cost Analysis
Humans
Health Care Costs
varicose ulcer
Compression Bandages
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
 Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases