Cost Evaluation of Venous Leg Ulcers Management

Varicose Ulcer Clinical Trial

— EPIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728986
• Other study ID #: FR Study No-05-000001
• Secondary ID: 2014-A01128-39
• Status: Completed
• Phase: N/A
• Start date: December 17, 2015
• Est. completion date: July 1, 2018

Study information

• Verified date: January 2019
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: July 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer

Intervention

Device:
• Profore
Profore multilayer compression bandage + standard regimen for wound care according to investigator's choice
• Coban2
Coban2 compression system + standard regimen for wound care according to investigator's choice

Locations

Country	Name	City	State
France	Quimper Center	Quimper

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Direct cost of leg ulcer management	Direct cost includes cost of bandages, dressings, nurse/doctor visits. Cost will be computed upon consumptions reported by healthcare professionals.	16 weeks
Secondary	Prevalence of adverse events related to compression	Number and type of adverse events related to compression bandages	16 weeks
Secondary	Patient's compression bandage acceptance score	Four ad hoc 7-level Likert scales will be used to assess bandage impact on daily activities, sleep, shoes and slippage	16 weeks
Secondary	Number of patients with fully healed ulcer	Full healing rate	16 weeks
Secondary	EuroQoL 5D-5L change between baseline and last visit	Quality of Life	16 weeks
Secondary	Average time to full healing		16 weeks