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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство 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)
• Устройство 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

Первичные конечные точки

• Complete closure of the Venous Leg Ulcer (VLU) [Срок оценки: 16-week treament period]

Вторичные конечные точки (2)

• Time to complete closure of the Venous Leg Ulcer (VLU) [Срок оценки: 16-week treament period]
• Safety analysis [Срок оценки: 16-week treament period]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 3 центра

• Patricia SENET, Paris, Paris 75000 — Paris
• Cabinet d'Angiologie - Médecine Vasculaire 377 rue Garibaldi 69007 LYON — Lyon
• APHP Hopital TENON Service de Dermatologie et médecine vasculaire 4 Rue de la Chine 75970 — Paris

Идентификаторы

NCT: NCT06899919 · ID RBC : 2024-A01402-45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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