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

13 mei 2026 bijgewerkt door: Molnlycke Health Care AB

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

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

386

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Frankrijk
      • Castelnau-le-Lez, Frankrijk
        • Clinique du Parc-Montpellier
        • Contact:
      • Grenoble, Frankrijk
        • CHU Michallon Grenoble
        • Contact:
      • Lyon, Frankrijk
      • Lyon, Frankrijk
        • Hopital Edouard Herriot_HCL
        • Contact:
      • Nantes, Frankrijk
      • Poitiers, Frankrijk
        • Poitiers Polyclinique
        • Contact:
      • Toulouse, Frankrijk
      • Toulouse, Frankrijk

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.-

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Mepi™ Press 2- two-layer compression bandage
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.
Apparaat: 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.
Apparaat: Wound Dressing Material
Appropriate primary wound dressing applied prior to compression therapy according to standard of care.
Actieve vergelijker: UrgoK2® - multicomponent, compression system
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.
Apparaat: Wound Dressing Material
Appropriate primary wound dressing applied prior to compression therapy according to standard of care.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of patients with complete healing of their VLU
Tijdsspanne: 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.
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Compare reduction of VLU wound area (absolute and relative).
Tijdsspanne: 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
Absolute and percentage VLU wound surface area reduction compared to baseline at all 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
Compare proportions of participants reaching 40% wound area reduction at 4 weeks
Tijdsspanne: 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)
Proportion of participants reaching ≥40% relative wound area reduction (RWAR) 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
Tijdsspanne: 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
Time to wound healed in each cohort, for patients with healed wound at termination.
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.
Tijdsspanne: 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
Quality of Life assessed with Wound-QoL-17 tool at each visit and change compared to baseline.
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
Tijdsspanne: 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
At each follow-up visit, participants will complete a usability questionnaire including Likert scale assessments.
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.
Tijdsspanne: 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
At each visit, the treating investigator will complete a usability questionnaire including Likert scale assessments; at baseline, only a limited set of questions will be collected.
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
Tijdsspanne: 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
A summary and comparison of the compression use, including frequency of dressing/compression changes and primary dressing used, and type and size of compression used in relation to ankle size
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.
Tijdsspanne: 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
A(D)E and SA(D)E and DD rates.
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Molnlycke Health Care AB

Medewerkers

Euraxi Pharma

Onderzoekers

  • Studie directeur: Arne Böhling, Mölnlycke Health Care AB

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 mei 2026

Primaire voltooiing (Geschat)

1 mei 2028

Studie voltooiing (Geschat)

1 mei 2028

Studieregistratiedata

Eerst ingediend

30 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 mei 2026

Eerst geplaatst (Werkelijk)

20 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

13 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • The Boa Clinical Investigation

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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