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Efficacy and Safety of Light Compression System in the Local Treatment of Mixed Leg Ulcers (PROMETHEE Clinical Investigation)
Sponsor: Laboratoires URGO
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
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
210
Start Date
2025-03-29
Completion Date
2027-09-30
Last Updated
2025-04-08
Healthy Volunteers
No
Conditions
Interventions
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
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