Venous Leg UlcerCOMPULCENCT02782689
Clinical Study to Assess Efficacy and Safety of a New Compression System in the Management of Venous Leg Ulcers
A study testing Kit Biflex and Profore in people with Venous Leg Ulcer, run by Thuasne at 1 site in France.
Trial summary
The primary objective of this study is to demonstrate the non-inferiority of the 2-layer compression system Kit Biflex® with regard of the 4-layer compression system PROFORE® in the treatment of venous leg ulcers in terms of complete healing at 16 weeks. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Kit Biflex and Profore
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Mar 2017
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients or outpatients.
- Agreeing to wear a multilayer compression system throughout the study period.
- Presenting with an active venous leg ulcer: Duration between 1-24 months (whether a new ulcer or a recurrent ulcer); Surface area between 2-50 cm2; Venous, superficial or post-thrombotic ulcer confirmed by Doppler ultrasonography (dated within six months).
- With ankle circumference between 18-25 cm to allow the laying of the compression system.
- Able to follow the study instructions.
- Having read the information sheet and dated and signed the informed consent form.
- Covered by a health insurance system.
Who cannot join
- Scheduled surgery for the ulcer during the 16 weeks following inclusion.
- Clinical superinfected ulcer not controlled oral antibiotics.
- Malignant ulcer.
- Ulcer surface totally covered with dry fibrinous tissue or covered with black necrotic plaque on over 10% of its surface.
- Deep Vein Thrombosis within the last 3 months.
- Corticosteroids treatment (equivalent to more than 10 mg per day of prednisolone) ongoing or planned during the study.
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- Radiotherapy, chemotherapy or immunosuppressive therapy ongoing or planned during the study.
- Erysipelas and lymphangitis.
- Lower extremity arterial disease or microangiopathy (Ankle Brachial Pressure Index <0.8 or> 1.3).
- Uncontrolled non-insulin dependent diabetes (HbA1c> 8%).
- Insulin-dependent diabetes.
- Confined to bed.
- With any uncontrolled severe and progressive disease.
- With a known or suspected hypersensitivity to any of the components of the study devices.
- Who had participated in a previous clinical study within the past 3 months.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy and Safety of the 2-layer Compression System Kit Biflex® Versus the 4-layer Compression System PROFORE® in the Management of Venous Leg Ulcers (Stage C6).
The primary objective of this study is to demonstrate the non-inferiority of the 2-layer compression system Kit Biflex® with regard of the 4-layer compression system PROFORE® in the treatment of venous leg ulcers in terms of complete healing at 16 weeks.
Read the detailed description
This trial is a multicentre, randomized, comparative, open label clinical study conducted in vascular medicine centres in France, with 2 parallel groups of 100 patients each. The study will be conducted in patients suffering from venous leg ulcer (stage C6 of the CEAP classification for chronic venous disorders).
The patients will be randomised at the inclusion: they will receive with either Kit Biflex® or the reference device (Profore®) for maximum 16 weeks (or until full healing).
Investigator assessments are planned every 4 weeks +/- 3 days, for 16 weeks.
- Conditions
- Venous Leg Ulcer
- Being tested
- Kit Biflex, Profore
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kit BiflexDevice
Two-layer reusable compression system
ProforeDevice
Four-layer compression system
| Study group | Role | What they receive |
|---|---|---|
| Kit Biflex | Experimental | The Kit Biflex® will be applied according to manufacturer recommendations for 16 weeks or until full healing. Receives: Device: Kit Biflex |
| Profore | Active comparator | The compression system Profore will be applied according to manufacturer recommendations for 16 weeks or until full healing. Receives: Device: Profore |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with complete wound closure (100% re-epithelialisation) over the treatment period
Measured: 16 weeks
Nature and frequency of adverse events
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 posted25 May 2016 (estimated)
- Study startJun 2014
- Primary completionDec 2016
- Study completionMar 2017
Why it stopped: difficulties in enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Luc GILLET, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782689
- Sponsor's protocol ID
- 2014-A00287-40
- Acronym
- COMPULCE
- Status last verified
- Apr 2018
- First submitted
- 23 May 2016
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of the 2-layer Compression System Kit Biflex® Versus the 4-layer Compression System PROFORE® in the Management of Venous Leg Ulcers (Stage C6).
- ClinicalTrials.gov ID
- NCT02782689
- Acronym / sponsor ID
- COMPULCE / 2014-A00287-40
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties in enrolling patients
- Enrolment
- 92 participants (actual)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 25 May 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 primary objective of this study is to demonstrate the non-inferiority of the 2-layer compression system Kit Biflex® with regard of the 4-layer compression system PROFORE® in the treatment of venous leg ulcers in terms of complete healing at 16 weeks.
Detailed description
This trial is a multicentre, randomized, comparative, open label clinical study conducted in vascular medicine centres in France, with 2 parallel groups of 100 patients each. The study will be conducted in patients suffering from venous leg ulcer (stage C6 of the CEAP classification for chronic venous disorders).
The patients will be randomised at the inclusion: they will receive with either Kit Biflex® or the reference device (Profore®) for maximum 16 weeks (or until full healing).
Investigator assessments are planned every 4 weeks +/- 3 days, for 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kit Biflex | Experimental | Device: Kit BiflexThe Kit Biflex® will be applied according to manufacturer recommendations for 16 weeks or until full healing. |
| Profore | Active comparator | Device: ProforeThe compression system Profore will be applied according to manufacturer recommendations for 16 weeks or until full healing. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Inpatients or outpatients.
- Agreeing to wear a multilayer compression system throughout the study period.
- Presenting with an active venous leg ulcer: Duration between 1-24 months (whether a new ulcer or a recurrent ulcer); Surface area between 2-50 cm2; Venous, superficial or post-thrombotic ulcer confirmed by Doppler ultrasonography (dated within six months).
- With ankle circumference between 18-25 cm to allow the laying of the compression system.
- Able to follow the study instructions.
Key exclusion criteria (16 listed)
- Scheduled surgery for the ulcer during the 16 weeks following inclusion.
- Clinical superinfected ulcer not controlled oral antibiotics.
- Malignant ulcer.
- Ulcer surface totally covered with dry fibrinous tissue or covered with black necrotic plaque on over 10% of its surface.
- Deep Vein Thrombosis within the last 3 months.
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 |
|---|---|---|
| Kit BiflexTwo-layer reusable compression system | Device | Kit Biflex |
| ProforeFour-layer compression system | Device | Profore |
Primary outcome
Percentage of patients with complete wound closure (100% re-epithelialisation) over the treatment period
Time frame: 16 weeks
Nature and frequency of adverse events
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: difficulties in enrolling patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
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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.
Jean-Luc GILLET, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kit Biflex and Profore in people with Venous Leg Ulcer, run by Thuasne 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 7 inclusion and 16 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: stopped early, as of the sponsor's last update on 26 Apr 2018. 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 was stopped early (reason given: difficulties in enrolling patients). Results are not available in the source record.
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?
Percentage of patients with complete wound closure (100% re-epithelialisation) over the treatment period (time frame: 16 weeks). The study lists 2 primary outcomes in all. 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 26 Apr 2018.