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

NCT07600489 | Not Yet Recruiting

• 1 other identifier: The Boa Clinical Investigation
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 8

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with complete healing of their VLU

  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.

  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

Secondary Outcomes (8)

• Compare reduction of VLU wound area (absolute and relative).

  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

  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

  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.

  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

  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

Study Arms (2)

Mepi™ Press 2- two-layer compression bandage

EXPERIMENTAL

Participants will receive compression therapy using Mepi™ Press 2 in accordance with standard of care for venous leg ulcer (VLU) management. Mepi™ Press 2 is a two-layer, short-stretch compression system consisting of a padded bandage and a cohesive compression bandage with visual application indicator. An appropriate primary wound dressing will be applied prior to compression. Bandages are worn continuously and changed as clinically indicated, typically up to once weekly. The system is intended to provide high working pressure and low resting pressure to support venous return and reduce edema. Single-use, non-sterile device.

Device: Compression bandage system (Mepi™ Press 2); Device: Wound Dressing Material

UrgoK2® - multicomponent, compression system

ACTIVE COMPARATOR

Participants will receive compression therapy using UrgoK2® in accordance with standard of care for venous leg ulcer (VLU) management. UrgoK2® is a two-layer compression system consisting of a white short-stretch bandage (K-TECH) and a pink/beige cohesive long-stretch bandage (Kpress) with visual indicators to support correct application and achieve therapeutic compression (approximately 40 mmHg). An appropriate primary wound dressing will be applied prior to compression. Bandages are worn continuously and changed as clinically indicated, typically up to once weekly. The system is non-sterile, intended for single use, available in different sizes based on ankle circumference.

Device: Compression bandage system (UrgoK2®); Device: Wound Dressing Material

Interventions

Compression bandage system (Mepi™ Press 2) DEVICE

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.

Mepi™ Press 2- two-layer compression bandage

Compression bandage system (UrgoK2®) DEVICE

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.

UrgoK2® - multicomponent, compression system

Wound Dressing Material DEVICE

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

Mepi™ Press 2- two-layer compression bandage; UrgoK2® - multicomponent, compression system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years.
• Stage C6 venous leg ulcer diagnosed less than 24 months ago.
• cm² ≤ 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.

You may not qualify if:

• Any contraindication to investigational or comparator medical devices mentioned in their respective IFUs.
• Treatment with chemotherapy or antineoplastic agent within the last 6 months.
• 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.-

Sponsors & Collaborators

• Molnlycke Health Care AB: lead
• Euraxi Pharma: collaborator

Study Sites (8)

Clinique du Parc-Montpellier

Castelnau-le-Lez, France

Location

CHU Michallon Grenoble

Grenoble, France

Location

Clinique du Parc Lyon

Lyon, France

Location

Hopital Edouard Herriot_HCL

Lyon, France

Location

CHU Nantes

Nantes, France

Location

Poitiers Polyclinique

Poitiers, France

Location

CHU Toulouse/Hopital Rangueil

Toulouse, France

Location

Clinique Pasteur-Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Bandages

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Arne Böhling

  Mölnlycke Health Care AB

  STUDY DIRECTOR

Central Study Contacts

Clinical Project Manager

CONTACT

+46 (0)31- 722 31 96; kristina.welinder@molnlycke.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

FR (8)