Venous Leg UlcerINVICTUSNCT03736941
Impact of Venotrain UlcerteC Venous Compression Device in the Treatment of Venous Ulcers in Daily Practice
A study testing Patients with venous leg in people with Venous Leg Ulcer, run by Fondation Hôpital Saint-Joseph at 2 sites in France.
Trial summary
The cornerstone of the management of venous leg or predominantly venous leg ulcers with IPS> 0.8 is venous compression as recommended by the HAS in June 2006. There is ample clinical evidence to support its importance to improve the chances of closure of this chronic lesion and shorten the healing time compared to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Patients with venous leg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Apr 2019to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient whose age is ≥ 18 years
- Patient with venous or predominantly venous leg ulcer as defined by HAS
- Patient with at least one supracleolar ulcer at stage C6 of CEAP
- Surface of the ulcer of the largest size ≤ 10 cm2
- IPS less than 6 months> 0.8 for both limbs or toe pressure ≥ 60 mmHg if mediacalcosis (SPI> 1.2)
- Patient with a maximum of three supraballeolar ulcers (one or two sided)
Show all 10Show fewer
- Patient followed by a hospital outpatient clinic in the departments of vascular medicine, angiology, internal medicine, dermatology or geriatric medicine (First consultation or not)
- Patient with walking ability over 50 m (with or without help)
- Patient with a prescription indication of Venetrain® Ulcertec Low Venous Compression System (Bauerfeind)
- Patient giving free, informed and written consent
Who cannot join
- Any other non-venous etiology of the ulcer in the opinion of the clinician
- Infections of lesions requiring the introduction of systemic antibiotic therapy
- Contraindication to treatment including venous compression by stockings
- Patient with cognitive impairment
- Patient to be hospitalized within 20 weeks after inclusion
- Patient with another wound than the leg ulcer (s) (especially foot ulcers, pressure ulcers)
- Patient with at least one very exudative ulcer, requiring the placement of a thick absorbent primary dressing incompatible with the use of compression stockings
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre hospitalier universitaire d'Angers
Angers, 49100
Groupe Hospitalier Paris Saint-Joseph
Paris, 75014
About this study
The cornerstone of the management of venous leg or predominantly venous leg ulcers with IPS> 0.8 is venous compression as recommended by the HAS in June 2006. There is ample clinical evidence to support its importance to improve the chances of closure of this chronic lesion and shorten the healing time compared to the absence of compression.
In 2016, a system of re-usable compression stockings (Venotrain® Ulcertec, BAUERFEIND, France), and bringing an interface pressure of 30 to 45 mmHg to the ankle according to the prescription, was taken over by the Health Insurance in France. 'Indication' Ulcer of venous origin or predominantly venous component, stage C6 CEAP classification with a systolic pressure index greater than 0.9 '.
The investigators propose to study the efficiency of Venotrain® Ulcertec in a diverse population in which it is prescribed according to the usual practices of venous leg ulceration of venous or predominantly venous origin.
Read the detailed description
The supra-malleolar leg ulcers of venous origin, in the C6 stage of the CEAP (unhealed venous ulcer), are characterized by the presence of two pulses (pedis and posterior tibial) or a Systolic Pressure Index (SPI) ≥ 0, 7 or a pressure of the big toe ≥ 60 mmHg or an arterial echo-doppler of the lower limbs revealing neither hemodynamic stenosis nor arterial occlusion.
The HAS working group defines a pure venous ulcer as a leg wound that has not healed for more than 1 month, related to an ambulatory venous hyperpressure. This hyperpressure may be secondary to superficial vein reflux and / or deep vein reflux or obstruction and / or calf pump deficiency. In the pure venous ulcer, there is no arterial involvement. The predominantly venous mixed ulcer is an ulcer with a preferentially venous mechanism but accompanied by a moderate arterial occlusion of the lower limbs which does not explain the symptomatology alone.
The fundamental element in the management of venous or predominantly venous leg ulcers with an SPI> 0.8 is venous compression as recommended by the June 2006 HAS.
Numerous clinical evidence confirms its importance for improving the chances of closure of this chronic lesion and shortening the healing time compared to the absence of compression.
It is a long treatment that can last several months, very restrictive for the patient and all the more so, that the perception of an improvement is far from immediate. In addition, the affected population is usually elderly, and the ulcer is a source of permanent discomfort, affecting the quality of life of the subjects and explaining frequent social isolation and depressed mood. Moreover, the cost of this treatment is sometimes dissuasive with a dependent burden for the patient who, sometimes, is unacceptable.
In 2016, a system of re-usable compression stockings (Venotrain® Ulcertec, BAUERFEIND, France), and bringing an interface pressure of 30 to 45 mmHg to the ankle according to the prescription, was taken over by the Health Insurance in France. 'indication' Ulcer of venous origin or predominantly venous component, stage C6 of the CEAP classification (ie not healed) with a systolic pressure index greater than 0,9 '. This type of device has demonstrated an efficiency of the same order as the multi-type or multi-band systems for the closure of venous ulcers.
The investigators can therefore hope for the use of this type of stockings, a simplification of the care, an improvement of the comfort of wearing and thus a reduction of the feeling of frustration on the part of the patients with main consequence a better acceptability.
- Conditions
- Venous Leg Ulcer
- Being tested
- Patients with venous leg
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with venous legOther
The medical device Venotrain® Ulcertec will be prescribed according to the indications supported by the Health Insurance and used according to the recommendations of the manufacturer. It will be dispensed in town pharmacies. After inclusion, follow-up visits are scheduled at 4, and 16 weeks (± 1 week) as well as an end-of-study visit, not later than 20 weeks after enrollment or in case of premature termination. follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Patients with venous leg | Experimental | After inclusion, the medical device Venotrain® Ulcertec will be prescribed according to the indications supported by the Health Insurance and used according to the recommendations of the manufacturer. Follow-up visits are scheduled at 4, and 16 weeks (± 1 week) as well as an end-of-study visit, not later than 20 weeks after enrollment or in case of premature termination. follow-up.
During the various visits, clinical data will be collected in the patient's medical file as well as the answers to the questionnaires. Receives: Other: Patients with venous leg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Optimal efficiency
The primary endpoint is the overall, center-level prevalence of optimal VENOTRAIN® Ulcertec compressive sock efficiency. Optimal efficiency is defined by the observation of an ulcer closure at the end of a maximum follow-up of 20 weeks without the need to change the type of compression system initially prescribed and without detecting local problems considered by the clinician as possibly related to the compressive device but not interfering with the patient's management.
Measured: Week 20
Secondary outcomes (8)
health-related quality of life EQ5D-5L
The patient will complete the questionnary during the 4 weeks's consultation. EQ-5D is a standardized instrument for measuring generic health status.The number of levels of severity was increased to five in this new version; having no problems, having slight problems, having moderate problems, having severe problems and being unable to do/having extreme problems.
Measured: Week 4
health-related quality of life EQ5D-5L
The patient will complete the questionnary during the 16 weeks's consultation. EQ-5D is a standardized instrument for measuring generic health status.The number of levels of severity was increased to five in this new version; having no problems, having slight problems, having moderate problems, having severe problems and being unable to do/having extreme problems.
Measured: Week 16
health-related quality of life EQ5D-5L
The patient will complete the questionnary during the 20 weeks's consultation. EQ-5D is a standardized instrument for measuring generic health status.The number of levels of severity was increased to five in this new version; having no problems, having slight problems, having moderate problems, having severe problems and being unable to do/having extreme problems.
Measured: Week 20
Prevalence of acceptable efficiency
The endpoint is the overall, center-level prevalence of acceptable VENOTRAIN® Ulcertec compressive sock efficiency. An acceptable efficiency will be defined according to the same criteria but at least one troublesome local event has been detected without requiring a temporary or permanent interruption of the compression system initially prescribed.
Measured: Week 20
Evaluation of the patient's adhesion of VENOTRAIN® Ulcertec compressive sock
If stop: frequency of use before stop (never, episodic, daily), date of stop, person having decided the stop, reason for stop, prescription of another system If current use: time of use, membership (daily wear, every other day or more, less than every other day, from time to time or never / almost), ease of use of the compression according to the Likert scale, overall acceptability of Likert scale compression
Measured: Week 4
Evaluation of the patient's adhesion of VENOTRAIN® Ulcertec compressive sock
If stop: frequency of use before stop (never, episodic, daily), date of stop, person having decided the stop, reason for stop, prescription of another system If current use: time of use, membership (daily wear, every other day or more, less than every other day, from time to time or never / almost), ease of use of the compression according to the Likert scale, overall acceptability of Likert scale compression
Measured: Week 16
Evaluation of the patient's adhesion of VENOTRAIN® Ulcertec compressive sock
If stop: frequency of use before stop (never, episodic, daily), date of stop, person having decided the stop, reason for stop, prescription of another system If current use: time of use, membership (daily wear, every other day or more, less than every other day, from time to time or never / almost), ease of use of the compression according to the Likert scale, overall acceptability of Likert scale compression
Measured: Week 20
Time's estimation to obtain complete closure
Time's estimation to obtain complete closure : Kaplan Meier Method
Measured: Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start16 Apr 2019
- Primary completion15 Apr 2022
- Study completion31 Dec 2023 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey P STANSAL, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736941
- Sponsor's protocol ID
- INVICTUS
- Acronym
- INVICTUS
- Status last verified
- Apr 2023
- First submitted
- 5 Nov 2018
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Venotrain UlcerteC Venous Compression Device in the Treatment of Venous Ulcers in Daily Practice
- ClinicalTrials.gov ID
- NCT03736941
- Acronym / sponsor ID
- INVICTUS / INVICTUS
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Nov 2018 (actual)
- 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 cornerstone of the management of venous leg or predominantly venous leg ulcers with IPS> 0.8 is venous compression as recommended by the HAS in June 2006. There is ample clinical evidence to support its importance to improve the chances of closure of this chronic lesion and shorten the healing time compared to the absence of compression.
In 2016, a system of re-usable compression stockings (Venotrain® Ulcertec, BAUERFEIND, France), and bringing an interface pressure of 30 to 45 mmHg to the ankle according to the prescription, was taken over by the Health Insurance in France. 'Indication' Ulcer of venous origin or predominantly venous component, stage C6 CEAP classification with a systolic pressure index greater than 0.9 '.
The investigators propose to study the efficiency of Venotrain® Ulcertec in a diverse population in which it is prescribed according to the usual practices of venous leg ulceration of venous or predominantly venous origin.
Detailed description
The supra-malleolar leg ulcers of venous origin, in the C6 stage of the CEAP (unhealed venous ulcer), are characterized by the presence of two pulses (pedis and posterior tibial) or a Systolic Pressure Index (SPI) ≥ 0, 7 or a pressure of the big toe ≥ 60 mmHg or an arterial echo-doppler of the lower limbs revealing neither hemodynamic stenosis nor arterial occlusion.
The HAS working group defines a pure venous ulcer as a leg wound that has not healed for more than 1 month, related to an ambulatory venous hyperpressure. This hyperpressure may be secondary to superficial vein reflux and / or deep vein reflux or obstruction and / or calf pump deficiency. In the pure venous ulcer, there is no arterial involvement. The predominantly venous mixed ulcer is an ulcer with a preferentially venous mechanism but accompanied by a moderate arterial occlusion of the lower limbs which does not explain the symptomatology alone.
The fundamental element in the management of venous or predominantly venous leg ulcers with an SPI> 0.8 is venous compression as recommended by the June 2006 HAS.
Numerous clinical evidence confirms its importance for improving the chances of closure of this chronic lesion and shortening the healing time compared to the absence of compression.
It is a long treatment that can last several months, very restrictive for the patient and all the more so, that the perception of an improvement is far from immediate. In addition, the affected population is usually elderly, and the ulcer is a source of permanent discomfort, affecting the quality of life of the subjects and explaining frequent social isolation and depressed mood. Moreover, the cost of this treatment is sometimes dissuasive with a dependent burden for the patient who, sometimes, is unacceptable.
In 2016, a system of re-usable compression stockings (Venotrain® Ulcertec, BAUERFEIND, France), and bringing an interface pressure of 30 to 45 mmHg to the ankle according to the prescription, was taken over by the Health Insurance in France. 'indication' Ulcer of venous origin or predominantly venous component, stage C6 of the CEAP classification (ie not healed) with a systolic pressure index greater than 0,9 '. This type of device has demonstrated an efficiency of the same order as the multi-type or multi-band systems for the closure of venous ulcers.
The investigators can therefore hope for the use of this type of stockings, a simplification of the care, an improvement of the comfort of wearing and thus a reduction of the feeling of frustration on the part of the patients with main consequence a better acceptability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with venous leg | Experimental | Other: Patients with venous legAfter inclusion, the medical device Venotrain® Ulcertec will be prescribed according to the indications supported by the Health Insurance and used according to the recommendations of the manufacturer. Follow-up visits are scheduled at 4, and 16 weeks (± 1 week) as well as an end-of-study visit, not later than 20 weeks after enrollment or in case of premature termination. follow-up. During the various visits, clinical data will be collected in the patient's medical file as well as the answers to the questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient whose age is ≥ 18 years
- Patient with venous or predominantly venous leg ulcer as defined by HAS
- Patient with at least one supracleolar ulcer at stage C6 of CEAP
- Surface of the ulcer of the largest size ≤ 10 cm2
- IPS less than 6 months> 0.8 for both limbs or toe pressure ≥ 60 mmHg if mediacalcosis (SPI> 1.2)
Key exclusion criteria (7 listed)
- Any other non-venous etiology of the ulcer in the opinion of the clinician
- Infections of lesions requiring the introduction of systemic antibiotic therapy
- Contraindication to treatment including venous compression by stockings
- Patient with cognitive impairment
- Patient to be hospitalized within 20 weeks after inclusion
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 |
|---|---|---|
| Patients with venous legThe medical device Venotrain® Ulcertec will be prescribed according to the indications supported by the Health Insurance and used according to the recommendations of the manufacturer. It will be dispensed in town pharmacies. After inclusion, follow-up visits are scheduled at 4, and 16 weeks (± 1 week) as well as an end-of-study visit, not later than 20 weeks after enrollment or in case of premature termination. follow-up. | Other | Patients with venous leg |
Primary outcome
Prevalence of Optimal efficiency
Time frame: Week 20
The primary endpoint is the overall, center-level prevalence of optimal VENOTRAIN® Ulcertec compressive sock efficiency. Optimal efficiency is defined by the observation of an ulcer closure at the end of a maximum follow-up of 20 weeks without the need to change the type of compression system initially prescribed and without detecting local problems considered by the clinician as possibly related to the compressive device but not interfering with the patient's management.
8 secondary outcomes
health-related quality of life EQ5D-5L
Time frame: Week 4
health-related quality of life EQ5D-5L
Time frame: Week 16
health-related quality of life EQ5D-5L
Time frame: Week 20
Prevalence of acceptable efficiency
Time frame: Week 20
Evaluation of the patient's adhesion of VENOTRAIN® Ulcertec compressive sock
Time frame: Week 4
Evaluation of the patient's adhesion of VENOTRAIN® Ulcertec compressive sock
Time frame: Week 16
Evaluation of the patient's adhesion of VENOTRAIN® Ulcertec compressive sock
Time frame: Week 20
Time's estimation to obtain complete closure
Time frame: Week 20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Audrey P STANSAL, MD principal investigator
Fondation Hôpital Saint-Joseph
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients with venous leg in people with Venous Leg Ulcer, run by Fondation Hôpital Saint-Joseph at 2 sites 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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Prevalence of Optimal efficiency (time frame: Week 20). 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 27 Apr 2023.