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Status:

RECRUITING

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

Lead Sponsor:

Laboratoires URGO

Conditions:

Leg Ulcers

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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...

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 st...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 29 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 30 2027

    Estimated Enrollment :

    210 Patients enrolled

    Trial Details

    Trial ID

    NCT06899919

    Start Date

    March 29 2025

    End Date

    September 30 2027

    Last Update

    April 8 2025

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Patricia SENET, Paris, Paris 75000

    Paris, Paris, France, 75000

    2

    Cabinet d'Angiologie - Médecine Vasculaire 377 rue Garibaldi 69007 LYON

    Lyon, France, 69007

    3

    APHP Hopital TENON Service de Dermatologie et médecine vasculaire 4 Rue de la Chine 75970 PARIS Cedex 20

    Paris, France, 75970