Cost Evaluation of Venous Leg Ulcers Management

Not Applicable

Completed

• Conditions: Varicose Ulcer
• Interventions: Device: Coban2; Device: Profore

• Registration Number: NCT02728986
• Lead Sponsor: Solventum US LLC

Brief Summary

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

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 Timeline

• Study Start: 2015-12-17
• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Primary Completion: 2018-06-01
• Study Completion: 2018-07-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compression2	Coban2	Coban2 compression system
Compression1	Profore	Multilayer compression bandage (Profore)

Primary Outcome Measures

Name	Time	Method
Direct cost of leg ulcer management	16 weeks	Direct cost includes cost of bandages, dressings, nurse/doctor visits. Cost will be computed upon consumptions reported by healthcare professionals.

Secondary Outcome Measures

Name	Time	Method
Patient's compression bandage acceptance score	16 weeks	Four ad hoc 7-level Likert scales will be used to assess bandage impact on daily activities, sleep, shoes and slippage
Number of patients with fully healed ulcer	16 weeks	Full healing rate
EuroQoL 5D-5L change between baseline and last visit	16 weeks	Quality of Life
Average time to full healing	16 weeks
Prevalence of adverse events related to compression	16 weeks	Number and type of adverse events related to compression bandages

Trial Locations

Locations (1)

Quimper Center; 🇫🇷 Quimper, France