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Efficacy and Safety of Light Compression System in the Local Treatment of Mixed Leg Ulcers (PROMETHEE Clinical Investigation)

RecruitingNAAges 18 Years - anyAllLaboratoires URGO
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * 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
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What it tests

  • 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
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Where

3 sites
Patricia SENET, Paris, Paris 75000
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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