Clinical trial NCT06899919: Efficacy and Safety of Light Compression System in the Local Treatment of Mixed Leg Ulcers (PROMETHEE Clinical Investigation)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leg Ulcers
Keywords: Mixed leg ulcers
Quality of life questionnaire
light compression system
Lead sponsor: Laboratoires URGO
Sponsor class: INDUSTRY
First posted: 2025-03-28
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomization 2:1 (light compression system vs tubular bandage)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Complete closure of the Venous Leg Ulcer (VLU)
timeFrame: 16-week treament period
Secondary outcomes:
measure: Time to complete closure of the Venous Leg Ulcer (VLU)
timeFrame: 16-week treament period
measure: Safety analysis
timeFrame: 16-week treament period
Other outcomes:
Locations:
city: Lyon
country: France
facility: Cabinet d'Angiologie - Médecine Vasculaire 377 rue Garibaldi 69007 LYON
city: Paris
country: France
facility: Patricia SENET, Paris, Paris 75000
city: Paris
country: France
facility: APHP Hopital TENON Service de Dermatologie et médecine vasculaire 4 Rue de la Chine 75970 PARIS Cedex 20
Study officials:
affiliation: Hôpitaux Universitaires Paris Est (AP-HP) - Hôpital TENON
name: Patricia PaS SENET, Dr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: