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

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

Conditions

• Venous Leg Ulcer (VLU)
• Compression Bandages

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

Wound Dressing Material

Appropriate primary wound dressing applied prior to compression therapy according to standard of care.

Sponsors & Collaborators

• Euraxi Pharma

  collaborator INDUSTRY

• Molnlycke Health Care AB

  lead INDUSTRY

Principal Investigators

• Arne Böhling · Mölnlycke Health Care AB

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2028-05-31

Completion

2028-05-31

Countries

• France

Study Locations