RecruitingNot ApplicableNCT06899919

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

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

Sponsor

Laboratoires URGO

Enrollment

210 participants

Start Date

Mar 29, 2025

Study Type

INTERVENTIONAL

Conditions

Leg Ulcers

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

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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

Exclusion Criteria6

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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Interventions

DEVICETreatment 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)

DEVICELight 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

Locations(3)

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

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NCT06899919

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