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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 386
- 试验地点
- 8
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.-