Efficacy and Safety of Light Compression System in the Local Treatment of Mixed Leg Ulcers (PROMETHEE Clinical Investigation)
NCT ID: NCT06899919
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
210 participants
INTERVENTIONAL
2025-03-29
2027-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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light compression system
Treatment with two bandages light compression system during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)
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)
Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classification
Etiological treatment of mixed leg ulcer stage C6 / C6r of the CEAP classification
tubular bandage
Treatment with tubular bandage system during 16-week treament period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)
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)
Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classification
Etiological treatment of mixed leg ulcer stage C6 / C6r of the CEAP classification
Interventions
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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)
Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classification
Etiological treatment of mixed leg ulcer stage C6 / C6r of the CEAP classification
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Laboratoires URGO
INDUSTRY
Responsible Party
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Principal Investigators
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Patricia PaS SENET, Dr, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hôpitaux Universitaires Paris Est (AP-HP) - Hôpital TENON
Locations
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Patricia SENET, Paris, Paris 75000
Paris, Paris, France
Cabinet d'Angiologie - Médecine Vasculaire 377 rue Garibaldi 69007 LYON
Lyon, , France
APHP Hopital TENON Service de Dermatologie et médecine vasculaire 4 Rue de la Chine 75970 PARIS Cedex 20
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ID RBC : 2024-A01402-45
Identifier Type: -
Identifier Source: org_study_id
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