Cost Evaluation of Venous Leg Ulcers Management (EPIC)

January 18, 2019 updated by: 3M

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

The purpose of this study is to evaluate direct costs of Venous Leg Ulcers (VLU) management when two different compression systems are used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Quimper, France
        • Quimper Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

3M

Investigators

  • Study Chair: Sylvie Meaume, MD, AP-HP Hôpital Rothschild - Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2015

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimate)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 18, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FR Study No-05-000001
  • 2014-A01128-39 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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