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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Wound Dressing Material: Appropriate primary wound dressing applied prior to compression therapy according to standard of care.

Study summary

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

Eligibility

Primary outcome measure(s)

• Percentage of patients with complete healing of their VLU — 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
  Healing assessment is performed by the site investigator through clinical examination of the wound at the investigational site, during each of the follow-up visits.

Trial sites (8)