Venous Leg UlcerFUTURENCT05158764
Efficacy and Safety of URGOBD001 Compression System
A study testing Venous compression system of the lower limbs stage C6 / C6r of the CEAP classification in people with Venous Leg Ulcer, run by Laboratoires URGO at 1 site in France.
Trial summary
Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of the new URGO BD001 compression system versus a reference compression in the local treatment of venous or mixed predominantly venous leg ulcers: prospective multicenter, randomized controlled… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Venous compression system of the lower limbs stage C6 / C6r of the CEAP classification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2021to 16 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patient (≥ 18 years old), having given free, informed and written consent
- Patient affiliated to a social security scheme
- Patient agreeing to wear the study compression system daily
- Patient with an ankle circumference between 18 and 25 cm
- Target wound: stage C6 / C6r leg ulcer of the CEAP classification with a 0.8≤ ABPI≤1.3
- Target wound with an area between 1 and 20 cm2
Show all 14Show fewer
- Target wound with age of ≤24 months
- Criteria exclusion:
- Patient with a systemic infection not controlled by appropriate antibiotic therapy
- Patient having presented in the 3 months preceding his inclusion, a deep vein thrombosis
- Patient with advanced stage II or stage III lymphoedema
- Patient bedridden or spending less than an hour per day standing
- Clinically infected target wound
- Cancerized target wound
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of the New URGO BD001 Compression System Versus a Reference Compression in the Local Treatment of Venous or Mixed Predominantly Venous Leg Ulcers: a Prospective Open-label RCT
Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of the new URGO BD001 compression system versus a reference compression in the local treatment of venous or mixed predominantly venous leg ulcers: prospective multicenter, randomized controlled, open-label clinical study
Read the detailed description
This is a prospective, randomized, controlled, open-label, multicenter clinical trial conducted in patients with a leg ulcer of venous or mixed predominantly venous origin of stage C6 / C6r of the CEAP classification.
This study is carried out in around 55 French investigational centers. A total of 178 patients meeting the eligibility criteria will be included. The patients will be followed for 12 weeks and a total of 5 clinical evaluations will be carried out by the investigating centers.
A planimetric survey of the studied VLU is carried out during the initial assessment of the wound (Day 0) and at each assessment provided for in the protocol (Week 2, Week 4, Week 8 and Week 12).
- Conditions
- Venous Leg Ulcer
- Being tested
- Venous compression system of the lower limbs stage C6 / C6r of the CEAP classification
- Keywords
- compression system, VLU, mixed VLU
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous compression system of the lower limbs stage C6 / C6r of the CEAP classificationDevice
Also called Etiological treatment of venous disease of the lower limbs stage C6 / C6r
Etiological treatment of venous disease of the lower limbs stage C6 / C6r
| Study group | Role | What they receive |
|---|---|---|
| URGO BD001 | Experimental | Treatment with URGO DB001 during 12-week treament period (5 medical visits are planned: D0, W2, W4, W8, W12) Receives: Device: Venous compression system of the lower limbs stage C6 / C6r of the CEAP classification |
| Kit Biflex | Active comparator | Treatment with Kit Biflex during 12-week treament period (5 medical visits are planned: D0, W2, W4, W8, W12 Receives: Device: Venous compression system of the lower limbs stage C6 / C6r of the CEAP classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete closure of the Venous Leg Ulcer (VLU)
Complete closure of the leg ulcer is defined by 100% re-epithelialization of the Venous Leg Ulcer (VLU)
Measured: 12-week treament period
Secondary outcomes (2)
Time to complete closure of the Venous Leg Ulcer (VLU)
Time to complete closure of the Venous Leg Ulcer (VLU) is defined as the time from inclusion to the date of complete closure
Measured: 12-week treament period
Safety analysis
Nature and number of adverse event related to the use of the studied compression system (serious/ non-serious)
Measured: 12-week treament period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start3 Dec 2021
- Primary completion6 Jul 2023
- Study completion16 Oct 2023
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
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires URGO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Dr SENET, MD, Principal investigator, Hôpitaux Universitaires Paris Est (AP-HP) - Hopital TENON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158764
- Sponsor's protocol ID
- ID RCB : 2021-A01874-37
- Acronym
- FUTURE
- Status last verified
- Oct 2023
- First submitted
- 29 Oct 2021
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of the New URGO BD001 Compression System Versus a Reference Compression in the Local Treatment of Venous or Mixed Predominantly Venous Leg Ulcers: a Prospective Open-label RCT
- ClinicalTrials.gov ID
- NCT05158764
- Acronym / sponsor ID
- FUTURE / ID RCB : 2021-A01874-37
- Conditions
- Venous Leg Ulcer
- Keywords
- compression system, VLU, mixed VLU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Laboratoires URGOIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 15 Dec 2021 (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.
Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of the new URGO BD001 compression system versus a reference compression in the local treatment of venous or mixed predominantly venous leg ulcers: prospective multicenter, randomized controlled, open-label clinical study
Detailed description
This is a prospective, randomized, controlled, open-label, multicenter clinical trial conducted in patients with a leg ulcer of venous or mixed predominantly venous origin of stage C6 / C6r of the CEAP classification.
This study is carried out in around 55 French investigational centers. A total of 178 patients meeting the eligibility criteria will be included. The patients will be followed for 12 weeks and a total of 5 clinical evaluations will be carried out by the investigating centers.
A planimetric survey of the studied VLU is carried out during the initial assessment of the wound (Day 0) and at each assessment provided for in the protocol (Week 2, Week 4, Week 8 and Week 12).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| URGO BD001 | Experimental | Device: Venous compression system of the lower limbs stage C6 / C6r of the CEAP classificationTreatment with URGO DB001 during 12-week treament period (5 medical visits are planned: D0, W2, W4, W8, W12) |
| Kit Biflex | Active comparator | Device: Venous compression system of the lower limbs stage C6 / C6r of the CEAP classificationTreatment with Kit Biflex during 12-week treament period (5 medical visits are planned: D0, W2, W4, W8, W12 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Adult patient (≥ 18 years old), having given free, informed and written consent
- Patient affiliated to a social security scheme
- Patient agreeing to wear the study compression system daily
- Patient with an ankle circumference between 18 and 25 cm
- Target wound: stage C6 / C6r leg ulcer of the CEAP classification with a 0.8≤ ABPI≤1.3
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Venous compression system of the lower limbs stage C6 / C6r of the CEAP classificationAlso: Etiological treatment of venous disease of the lower limbs stage C6 / C6rEtiological treatment of venous disease of the lower limbs stage C6 / C6r | Device | Kit Biflex, URGO BD001 |
Primary outcome
Complete closure of the Venous Leg Ulcer (VLU)
Time frame: 12-week treament period
Complete closure of the leg ulcer is defined by 100% re-epithelialization of the Venous Leg Ulcer (VLU)
2 secondary outcomes
Time to complete closure of the Venous Leg Ulcer (VLU)
Time frame: 12-week treament period
Safety analysis
Time frame: 12-week treament period
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 17 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Patricia Dr SENET, MD principal investigator
Hôpitaux Universitaires Paris Est (AP-HP) - Hopital TENON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venous compression system of the lower limbs stage C6 / C6r of the CEAP classification in people with Venous Leg Ulcer, run by Laboratoires URGO 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 14 inclusion and 0 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 17 Oct 2023. 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?
Complete closure of the Venous Leg Ulcer (VLU) (time frame: 12-week treament period). 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 17 Oct 2023.