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

13. mai 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

386

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Frankrike
      • Castelnau-le-Lez, Frankrike
        • Clinique du Parc-Montpellier
        • Ta kontakt med:
      • Grenoble, Frankrike
        • CHU Michallon Grenoble
        • Ta kontakt med:
      • Lyon, Frankrike
      • Lyon, Frankrike
        • Hopital Edouard Herriot_HCL
        • Ta kontakt med:
      • Nantes, Frankrike
      • Poitiers, Frankrike
        • Poitiers Polyclinique
        • Ta kontakt med:
      • Toulouse, Frankrike
      • Toulouse, Frankrike
        • Clinique Pasteur-Toulouse
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.-

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Enhet: Wound Dressing Material
Appropriate primary wound dressing applied prior to compression therapy according to standard of care.
Aktiv komparator: 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.
Enhet: Wound Dressing Material
Appropriate primary wound dressing applied prior to compression therapy according to standard of care.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of patients with complete healing of their VLU
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Compare reduction of VLU wound area (absolute and relative).
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Molnlycke Health Care AB

Samarbeidspartnere

Euraxi Pharma

Etterforskere

  • Studieleder: Arne Böhling, Mölnlycke Health Care AB

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mai 2026

Primær fullføring (Antatt)

1. mai 2028

Studiet fullført (Antatt)

1. mai 2028

Datoer for studieregistrering

Først innsendt

30. april 2026

Først innsendt som oppfylte QC-kriteriene

13. mai 2026

Først lagt ut (Faktiske)

20. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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