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

URGO Group

Status: Enrolling

Conditions: Leg Ulcers

Treatments: Device: Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classification; Device: Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06899919

ID RBC : 2024-A01402-45

Details and patient eligibility

About

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

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups, including a placebo group

light compression system

Experimental group

Description:

Treatment with two bandages light compression system during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)

Treatment:

Device: Treatment with light compression systeme 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

tubular bandage

Placebo Comparator group

Description:

Treatment with tubular bandage system during 16-week treament period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)

Treatment:

Device: Treatment with light compression systeme 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