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Completed

NCT Number: NCT02728986

Cost Evaluation of Venous Leg Ulcers Management

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

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Key information

Conditions

Varicose Ulcer Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Veins Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Quimper Center

Quimper, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Profore

Device

Profore multilayer compression bandage + standard regimen for wound care according to investigator's choice

Coban2

Device

Coban2 compression system + standard regimen for wound care according to investigator's choice

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M

Registry information

Official study title

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

Acronym: EPIC

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2016
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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