NCT02728986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

2.5 years

First QC Date

March 29, 2016

Last Update Submit

November 27, 2024

Conditions

Varicose Ulcer

Keywords

Costs and Cost AnalysisHumansHealth Care Costsvaricose ulcerCompression Bandages

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Prevalence of adverse events related to compression

    16 weeks

  • Patient's compression bandage acceptance score

    16 weeks

  • Number of patients with fully healed ulcer

    16 weeks

  • EuroQoL 5D-5L change between baseline and last visit

    16 weeks

  • Average time to full healing

    16 weeks

Study Arms (2)

Compression1

ACTIVE COMPARATOR

Multilayer compression bandage (Profore)

Device: Profore

Compression2

EXPERIMENTAL

Coban2 compression system

Device: Coban2

Interventions

ProforeDEVICE

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

Compression1
Coban2DEVICE

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

Compression2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • consent to participate
  • ambulatory management
  • 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

You may not qualify if:

  • cognitive impairment
  • opposition to wear compression bandage
  • bedridden
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quimper Center

Quimper, France

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sylvie Meaume, MD

    AP-HP Hôpital Rothschild - Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 6, 2016

Study Start

December 17, 2015

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations

FR(1)