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

13 maja 2026 zaktualizowane przez: 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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

386

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.-

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Urządzenie: 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.
Urządzenie: Wound Dressing Material
Appropriate primary wound dressing applied prior to compression therapy according to standard of care.
Aktywny 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.
Urządzenie: Wound Dressing Material
Appropriate primary wound dressing applied prior to compression therapy according to standard of care.
Urządzenie: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of patients with complete healing of their VLU
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Compare reduction of VLU wound area (absolute and relative).
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Molnlycke Health Care AB

Współpracownicy

Euraxi Pharma

Śledczy

  • Dyrektor Studium: Arne Böhling, Mölnlycke Health Care AB

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 maja 2026

Zakończenie podstawowe (Szacowany)

1 maja 2028

Ukończenie studiów (Szacowany)

1 maja 2028

Daty rejestracji na studia

Pierwszy przesłany

30 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 maja 2026

Pierwszy wysłany (Rzeczywisty)

20 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

20 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • The Boa Clinical Investigation

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Compression bandage system (Mepi™ Press 2)

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