Varicose UlcerEPICNCT02728986
Cost Evaluation of Venous Leg Ulcers Management
A study testing Profore and Coban2 in people with Varicose Ulcer, run by Solventum US LLC at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Varicose Ulcer
- What is being tested?
- Profore and Coban2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2015to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- cognitive impairment
- opposition to wear compression bandage
- bedridden
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative and Prospective Evaluation of Direct Cost of Venous Leg Ulcers Management With Two Compression Systems
The purpose of this study is to evaluate direct costs of Venous Leg Ulcers (VLU) management when two different compression systems are used.
Read the 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.
- Conditions
- Varicose Ulcer
- Being tested
- Profore, Coban2
- Keywords
- Costs and Cost Analysis, Humans, Health Care Costs, varicose ulcer, Compression Bandages
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProforeDevice
Profore multilayer compression bandage + standard regimen for wound care according to investigator's choice
Coban2Device
Coban2 compression system + standard regimen for wound care according to investigator's choice
| Study group | Role | What they receive |
|---|---|---|
| Compression1 | Active comparator | Multilayer compression bandage (Profore) Receives: Device: Profore |
| Compression2 | Experimental | Coban2 compression system Receives: Device: Coban2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (5)
Prevalence of adverse events related to compression
Number and type of adverse events related to compression bandages
Measured: 16 weeks
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
Measured: 16 weeks
Number of patients with fully healed ulcer
Full healing rate
Measured: 16 weeks
EuroQoL 5D-5L change between baseline and last visit
Quality of Life
Measured: 16 weeks
Average time to full healing
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study start17 Dec 2015
- Primary completion1 Jun 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Sylvie Meaume, MD, Study chair, AP-HP Hôpital Rothschild - Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728986
- Sponsor's protocol ID
- FR Study No-05-000001
- Other IDs
- 2014-A01128-39
- Acronym
- EPIC
- Status last verified
- Nov 2024
- First submitted
- 29 Mar 2016
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative and Prospective Evaluation of Direct Cost of Venous Leg Ulcers Management With Two Compression Systems
- ClinicalTrials.gov ID
- NCT02728986
- Acronym / sponsor ID
- EPIC / FR Study No-05-000001
- Conditions
- Varicose Ulcer
- Keywords
- Costs and Cost Analysis, Humans, Health Care Costs, varicose ulcer, Compression Bandages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- 17 Dec 2015 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compression1 | Active comparator | Device: ProforeMultilayer compression bandage (Profore) |
| Compression2 | Experimental | Device: Coban2Coban2 compression system |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- cognitive impairment
- opposition to wear compression bandage
- bedridden
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProforeProfore multilayer compression bandage + standard regimen for wound care according to investigator's choice | Device | Compression1 |
| Coban2Coban2 compression system + standard regimen for wound care according to investigator's choice | Device | Compression2 |
Primary outcome
Direct cost of leg ulcer management
Time frame: 16 weeks
Direct cost includes cost of bandages, dressings, nurse/doctor visits. Cost will be computed upon consumptions reported by healthcare professionals.
5 secondary outcomes
Prevalence of adverse events related to compression
Time frame: 16 weeks
Patient's compression bandage acceptance score
Time frame: 16 weeks
Number of patients with fully healed ulcer
Time frame: 16 weeks
EuroQoL 5D-5L change between baseline and last visit
Time frame: 16 weeks
Average time to full healing
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Varicose Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Meaume, MD study chair
AP-HP Hôpital Rothschild - Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Profore and Coban2 in people with Varicose Ulcer, run by Solventum US LLC at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Direct cost of leg ulcer management (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.