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

Launched by LABORATOIRES URGO · Mar 21, 2025

Keywords

ClinConnect Summary

The PROMETHEE clinical trial is studying a new light compression system to see how well it helps heal mixed leg ulcers compared to a standard tubular bandage. The trial aims to understand how effectively the wound heals and how long it takes for the wound to close. Researchers will also keep track of any side effects participants might experience while using the new compression system.

To be eligible for this trial, you need to be an adult (18 years or older) who agrees to wear the compression system every day. You should have a specific type of mixed leg ulcer that meets certain medical criteria, and your ulcer must be between 2 and 20 square centimeters in size. If you have certain conditions, like an uncontrolled infection or severe artery problems, you may not be able to participate. If you join the study, you’ll receive the new compression system to wear on your leg and will be monitored closely for your wound's healing progress. The trial is currently recruiting participants, and both men and women are welcome to join.

Gender

ALL

Eligibility criteria

• 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