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RECRUITING
NCT06899919
NA

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

Sponsor: Laboratoires URGO

View on ClinicalTrials.gov

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

DEVICE

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)

DEVICE

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