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Cost Evaluation of Venous Leg Ulcers Management

NCT ID: NCT02728986

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-17

Study Completion Date

2018-07-01

Brief Summary

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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

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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.

Conditions

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Varicose Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Compression1

Multilayer compression bandage (Profore)

Group Type ACTIVE_COMPARATOR

Profore

Intervention Type DEVICE

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

Compression2

Coban2 compression system

Group Type EXPERIMENTAL

Coban2

Intervention Type DEVICE

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

Interventions

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Profore

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

Intervention Type DEVICE

Coban2

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

Solventum US LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sylvie Meaume, MD

Role: STUDY_CHAIR

AP-HP Hôpital Rothschild - Paris

Locations

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Quimper Center

Quimper, , France

Site Status

Countries

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France

Other Identifiers

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2014-A01128-39

Identifier Type: OTHER

Identifier Source: secondary_id

FR Study No-05-000001

Identifier Type: -

Identifier Source: org_study_id