Leg UlcersPROMETHEENCT06899919
Efficacy and Safety of Light Compression System in the Local Treatment of Mixed Leg Ulcers (PROMETHEE Clinical Investigation)
A study testing Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16) and Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classification in people with Leg Ulcers, run by Laboratoires URGO at 3 sites in France.
Trial summary
Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of a lite compression system versus a tubular bandage in the local treatment of mixed leg ulcers: prospective multicenter, randomized controlled, open-label french clinical study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcers
- What is being tested?
- Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16) and Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classification
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 3 sitesFrance
- Study dates
- 29 Mar 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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 mixed leg ulcer of the CEAP classification with a 0.6≤ ABPI≤0.8 and TABP≥ 50 mm Hg and arterial echo Doppler confirming the mixed nature of the leg ulcer
- Target wound with an area between 2 and 20 cm2
Show all 14Show fewer
- Target wound with age of ≤18 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
- Severe arterial pathology, including an Ankle Blood Pressure Index (ABPI) less than 3 months old <0.6
- 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
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Cabinet d'Angiologie - Médecine Vasculaire 377 rue Garibaldi 69007 LYON
Lyon, 69007
Azeddine AzA ADDALA, MD, +33 4 78 72 38 98, a.addala@orange.fr
- Not yet recruiting
Patricia SENET, Paris, Paris 75000
Paris, Paris, 75000
Anne AnS SAUVADET, Dr, PhD, +33 6 71 19 78 91 ext. +33 3 80442884, a.sauvadet@fr.urgo.com
Olivier OlT TACCA, Dr, PhD, +33 3 80 44 74 22, o.tacca@fr.urgo
- Not yet recruiting
APHP Hopital TENON Service de Dermatologie et médecine vasculaire 4 Rue de la Chine 75970 PARIS Cedex 20
Paris, 75970
Patricia PaS SENET, MD, PhD, +33 1 56 01 76 11, patricia.senet@aphp.fr
About this study
Official title: Evaluation of the Efficacy and Safety of Light Compression System Versus Tubular Bandage in the Local Treatment of Mixed 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 a lite compression system versus a tubular bandage in the local treatment of mixed leg ulcers: prospective multicenter, randomized controlled, open-label french clinical study
Read the detailed description
This is a prospective, randomized, controlled, open-label, multicenter clinical trial conducted in patients with a mixed (non-ischemic) leg ulcer of stage C6 / C6r of the CEAP classification.
This study is carried out in around 50 French investigational centers. A total of 210 patients meeting the eligibility criteria will be included. The patients will be followed for 16 weeks and a total of 6 clinical evaluations will be carried out by the investigating centers.
A planimetric survey of the studied leg ulcers 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).
A QoL is carried out at D0 and end of the study for each patient included in the protocol.
- Conditions
- Leg Ulcers
- Being tested
- Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16), Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classification
- Keywords
- Mixed leg ulcers, Quality of life questionnaire, light compression system
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)Device
Treatment with light compression system during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)
Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classificationDevice
Etiological treatment of mixed leg ulcer stage C6 / C6r of the CEAP classification
| Study group | Role | What they receive |
|---|---|---|
| light compression system | Experimental | Treatment with two bandages light compression system during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16) Receives: Device: Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16); Device: Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classification |
| tubular bandage | Placebo comparator | Treatment with tubular bandage system during 16-week treament period (6 medical visits are planned: D0, W2, W4, W8, W12, W16) Receives: Device: Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16); Device: Light compression system of the mixed leg ulcer 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)
Description: Complete closure of the leg ulcer is defined by 100% re-epithelialization of the mixed Leg Ulcer (MLU)
Measured: 16-week treament period
Secondary outcomes (2)
Time to complete closure of the Venous Leg Ulcer (VLU)
Description: Time to complete closure of the Mixed Leg Ulcer (MLU) is defined as the time from inclusion to the date of complete closure
Measured: 16-week treament period
Safety analysis
Nature and number of adverse event related to the use of the studied light compression system and tubular bandage (serious/ non-serious and emergent)
Measured: 16-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 posted28 Mar 2025
- Study start29 Mar 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcersStudies 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
- Model description
- randomization 2:1 (light compression system vs tubular bandage)
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires URGO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia PaS SENET, Dr, MD, PhD, Principal investigator, Hôpitaux Universitaires Paris Est (AP-HP) - Hôpital TENON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899919
- Sponsor's protocol ID
- ID RBC : 2024-A01402-45
- Acronym
- PROMETHEE
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Light Compression System Versus Tubular Bandage in the Local Treatment of Mixed Leg Ulcers: a Prospective Open-label RCT
- ClinicalTrials.gov ID
- NCT06899919
- Acronym / sponsor ID
- PROMETHEE / ID RBC : 2024-A01402-45
- Conditions
- Leg Ulcers
- Keywords
- Mixed leg ulcers, Quality of life questionnaire, light compression system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Laboratoires URGOIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 28 Mar 2025 (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 a lite compression system versus a tubular bandage in the local treatment of mixed leg ulcers: prospective multicenter, randomized controlled, open-label french clinical study
Detailed description
This is a prospective, randomized, controlled, open-label, multicenter clinical trial conducted in patients with a mixed (non-ischemic) leg ulcer of stage C6 / C6r of the CEAP classification.
This study is carried out in around 50 French investigational centers. A total of 210 patients meeting the eligibility criteria will be included. The patients will be followed for 16 weeks and a total of 6 clinical evaluations will be carried out by the investigating centers.
A planimetric survey of the studied leg ulcers 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).
A QoL is carried out at D0 and end of the study for each patient included in the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomization 2:1 (light compression system vs tubular bandage)
| Arm | Type | Receives |
|---|---|---|
| light compression system | Experimental | Device: Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16), Device: Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classificationTreatment with two bandages light compression system during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16) |
| tubular bandage | Placebo comparator | Device: Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16), Device: Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classificationTreatment with tubular bandage system during 16-week treament period (6 medical visits are planned: D0, W2, W4, W8, W12, W16) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 mixed leg ulcer of the CEAP classification with a 0.6≤ ABPI≤0.8 and TABP≥ 50 mm Hg and arterial echo Doppler confirming the mixed nature of the leg ulcer
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 |
|---|---|---|
| Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)Treatment with light compression system during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16) | Device | light compression system, tubular bandage |
| Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classificationEtiological treatment of mixed leg ulcer stage C6 / C6r of the CEAP classification | Device | light compression system, tubular bandage |
Primary outcome
Complete closure of the Venous Leg Ulcer (VLU)
Time frame: 16-week treament period
Description: Complete closure of the leg ulcer is defined by 100% re-epithelialization of the mixed Leg Ulcer (MLU)
2 secondary outcomes
Time to complete closure of the Venous Leg Ulcer (VLU)
Time frame: 16-week treament period
Safety analysis
Time frame: 16-week treament period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
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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.
Patricia PaS SENET, Dr, MD, PhD principal investigator
Hôpitaux Universitaires Paris Est (AP-HP) - Hôpital TENON
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16) and Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classification in people with Leg Ulcers, run by Laboratoires URGO at 3 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 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: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne AnS SAUVADET, Dr, PhD (+33 6 71 19 78 91 ext. +33 38044284, a.sauvadet@fr.urgo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete closure of the Venous Leg Ulcer (VLU) (time frame: 16-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 8 Apr 2025.