EPIC: Cost Evaluation of Venous Leg Ulcers Management

• Sponsor: 3M (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02728986
• Collaborator: (none)
• Enrollment: 176
• Location: 1
• Arms: 2
• Actual Duration (Months): 30.5
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Varicose Ulcer	Device: Profore; Device: Coban2	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Comparative and Prospective Evaluation of Direct Cost of Venous Leg Ulcers Management With Two Compression Systems
• Actual Study Start Date: Dec 17, 2015
• Actual Primary Completion Date: Jun 1, 2018
• Actual Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Compression1 Multilayer compression bandage (Profore)	Device: Profore; Profore multilayer compression bandage + standard regimen for wound care according to investigator's choice
Experimental: Compression2 Coban2 compression system	Device: Coban2; Coban2 compression system + standard regimen for wound care according to investigator's choice

Outcome Measures

Primary Outcome Measures

1. 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

1. Prevalence of adverse events related to compression [16 weeks]

   Number and type of adverse events related to compression bandages

2. 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

3. Number of patients with fully healed ulcer [16 weeks]

   Full healing rate

4. EuroQoL 5D-5L change between baseline and last visit [16 weeks]

   Quality of Life

5. Average time to full healing [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quimper Center	Quimper		France

Sponsors and Collaborators

• 3M

Investigators

• Study Chair: Sylvie Meaume, MD, AP-HP Hôpital Rothschild - Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: 3M
• ClinicalTrials.gov Identifier: NCT02728986
• Other Study ID Numbers: FR Study No-05-000001; 2014-A01128-39
• First Posted: Apr 6, 2016
• Last Update Posted: Jan 22, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by 3M: Costs and Cost Analysis; Humans; Health Care Costs; varicose ulcer; Compression Bandages
• Additional relevant MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer

Study Results

No Results Posted as of Jan 22, 2019