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

Not Applicable

Recruiting

• Conditions: Leg Ulcers

• Registration Number: NCT06899919
• Lead Sponsor: Laboratoires URGO

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 of mixed leg ulcers: prospective multicenter, randomized controlled, open-label french clinical study

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 study is carried out in around 50 French investigational centers. A total of 210 patients meeting the eligibility criteria will be included. The patients will be followed for 16 weeks and a total of 6 clinical evaluations will be carried out by the investigating centers.

A planimetric survey of the studied leg ulcers is carried out during the initial assessment of the wound (Day 0) and at each assessment provided for in the protocol (Week 2, Week 4, Week 8 and Week 12).

A QoL is carried out at D0 and end of the study for each patient included in the protocol.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-21
• Study First Posted: 2025-03-28
• Study Start: 2025-03-29
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08
• Primary Completion: 2027-03-31
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complete closure of the Venous Leg Ulcer (VLU)	16-week treament period	Description: Complete closure of the leg ulcer is defined by 100% re-epithelialization of the mixed Leg Ulcer (MLU)

Secondary Outcome Measures

Name	Time	Method
Time to complete closure of the Venous Leg Ulcer (VLU)	16-week treament period	Description: Time to complete closure of the Mixed Leg Ulcer (MLU) is defined as the time from inclusion to the date of complete closure
Safety analysis	16-week treament period	Nature and number of adverse event related to the use of the studied light compression system and tubular bandage (serious/ non-serious and emergent)

Trial Locations

Locations (3)

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

Patricia SENET, Paris, Paris 75000; 🇫🇷 Paris, France