Cost Evaluation of Venous Leg Ulcers Management (EPIC)

Solventum US LLC

Status: Completed

Conditions: Varicose Ulcer

Treatments: Device: Profore; Device: Coban2

Study type: Interventional

Funder types: Industry

Identifiers

NCT02728986

FR Study No-05-000001

2014-A01128-39 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 176 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

Compression1

Active Comparator group

Description:

Multilayer compression bandage (Profore)

Treatment:

Device: Profore

Compression2

Experimental group

Description:

Coban2 compression system

Treatment:

Device: Coban2