A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers

Официальное название

A Comparative, Adaptive, Randomized, Non-Inferiority Clinical Investigation of Two-Layer Compression Bandages Mepi™ Press 2 Versus UrgoK2® in the Treatment of Venous Leg Ulcers

Обзор

Venous leg ulcers (VLUs) account for approximately 70% of all lower limb ulcers and affect an estimated 0.032% to 1% of the population in Western countries, corresponding to approximately 265,000 to 650,000 individuals in France. Effective management of VLUs is essential to reduce patient burden and associated healthcare costs. Compression therapy is the cornerstone of VLU treatment , as it improves venous return, reduces oedema, and promotes wound healing. Multilayer compression bandage systems, including two-layer systems, are considered the gold standard, and in France, they are recommended as first-line treatment for VLUs. The goal of this clinical trial is to evaluate whether the Mepi™ Press 2 compression system is non-inferior to UrgoK2® in the treatment of venous leg ulcers in adult patients. The main question it aims to answer is: -Is Mepi™ Press 2 non-inferior to UrgoK2® in terms of the proportion of completely healed VLUs within 12 weeks? Researchers will compare Mepi™ Press 2 with UrgoK2® to determine whether similar clinical efficacy, performance, and safety can be achieved. Participants are adult patients with venous leg ulcers of less than 24 months duration requiring treatment with a two-layer compression bandage system. The study is multicenter, involving approximately 25 sites in France, and plans to enroll 386 participants. Participants will: * Receive compression therapy with either Mepi™ Press 2 or UrgoK2® in accordance with standard of care * Receive an appropriate primary wound dressing prior to compression * Attend up to five study visits over a period of up to 12 weeks (or until wound healing, whichever occurs first) * Be assessed for wound healing, safety, and device performance throughout the study

Вмешательства

• Устройство Compression bandage system (Mepi™ Press 2)
  A two-layer compression system consisting of a padded bandage and a cohesive short-stretch bandage with visual indicator. Provides therapeutic compression to support venous leg ulcer management. Applied with an appropriate primary wound dressing and changed as clinically indicated.
• Устройство Compression bandage system (UrgoK2®)
  A two-layer compression system composed of a short-stretch bandage and a cohesive long-stretch bandage designed to achieve therapeutic compression (\~40 mmHg). Used for venous leg ulcer management with an appropriate primary wound dressing.
• Устройство Wound Dressing Material
  Appropriate primary wound dressing applied prior to compression therapy according to standard of care.

Первичные конечные точки

• Percentage of patients with complete healing of their VLU [Срок оценки: From enrollment to the end of treatment at 12 weeks, Visit 1(Day 0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0+ 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s]

Вторичные конечные точки (8)

• Compare reduction of VLU wound area (absolute and relative). [Срок оценки: From enrollment to the end of treatment at 12 weeks, Visit 1(Day 0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0+ 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s]
• Compare proportions of participants reaching 40% wound area reduction at 4 weeks [Срок оценки: From enrollment to the follow-up visit at 4 weeks, Visit 1(Day 0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days)]
• Compare time to complete wound healing [Срок оценки: From enrollment to the end of treatment at 12 weeks, Visit 1(Day 0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0+ 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s]
• Compare quality-of-life during treatment and up to 12 weeks. [Срок оценки: From enrollment to the end of treatment at 12 weeks, Visit 0 (D0) , Visit 1 (D0 + 2 weeks ± 1 day) ,Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0 + 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s]
• Compare comfort and usability as rated by the participant [Срок оценки: From enrollment to the end of treatment at 12 weeks, Visit 1 (D0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0 + 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s]
• Compare usability as rated by the healthcare professional. [Срок оценки: From enrollment to the end of treatment at 12 weeks, Visit 0 (D0), Visit 1 (D0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0 + 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s]
• Compare device use including frequency of change [Срок оценки: From enrollment to the end of treatment at 12 weeks, Visit 0 (D0), Visit 1 (D0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0 + 8 weeks ± 4 days),Visit 4 (D0 + 12 weeks ± 4 day)s]
• Compare safety profiles of both bandages. [Срок оценки: From enrollment to the end of treatment at 12 weeks,Visit 1 (D0 + 2 weeks ± 1 day), Visit 2 (D0 + 4 weeks ± 3 days), Visit 3 (D0 + 8 weeks ± 4 days), Visit 4 (D0 + 12 weeks ± 4 day)s]

Критерии участия

Критерии включения

• Patients ≥ 18 years.
• Stage C6 venous leg ulcer diagnosed less than 24 months ago.
• 2cm² ≤ VLU surface area ≤ 40cm².
• ABPI equal or higher than 0.8 and equal or lower than 1.3.
• Able to read, understand and speak French for their medical care.
• Agreeing to follow the procedures described in the CIP.
• Benefiting from a social insurance coverage.

Критерии исключения

• Any contraindication to investigational or comparator medical devices mentioned in their respective IFUs.
• Planned endovenous treatment or surgical venous stripping / exeresis within 8 weeks before planned inclusion date, or before end of participation to the study.
• Treatment with chemotherapy or antineoplastic agent within the last 6 months.
• Active wound infection or wound infection treatment within the past 4 weeks before inclusion or current use of silver dressings.
• Pregnant or breastfeeding women.
• Persons deprived from their liberty.
• Persons protected under guardianship or curatorship.
• Any person who, as per investigator's decision, is not suitable to participate in the investigation for any other reason.-

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 · 8 центров

• Clinique du Parc-Montpellier — Castelnau-le-Lez
• CHU Michallon Grenoble — Grenoble
• Clinique du Parc Lyon — Lyon
• Hopital Edouard Herriot_HCL — Lyon
• CHU Nantes — Nantes
• Poitiers Polyclinique — Poitiers
• CHU Toulouse/Hopital Rangueil — Toulouse
• Clinique Pasteur-Toulouse — Toulouse

Идентификаторы

NCT: NCT07600489 · The Boa Clinical Investigation

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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