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

13 de maio de 2026 atualizado por: 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

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

386

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • França
      • Castelnau-le-Lez, França
        • Clinique du Parc-Montpellier
        • Contato:
      • Grenoble, França
        • CHU Michallon Grenoble
        • Contato:
      • Lyon, França
      • Lyon, França
        • Hopital Edouard Herriot_HCL
        • Contato:
      • Nantes, França
      • Poitiers, França
        • Poitiers Polyclinique
        • Contato:
          • Principal Investigator
          • Número de telefone: +33 5 49 61 70 00
          • E-mail: dr.kassab@pdp86.fr
      • Toulouse, França
      • Toulouse, França

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.-

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Dispositivo: 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.
Dispositivo: Wound Dressing Material
Appropriate primary wound dressing applied prior to compression therapy according to standard of care.
Comparador Ativo: 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.
Dispositivo: Wound Dressing Material
Appropriate primary wound dressing applied prior to compression therapy according to standard of care.
Dispositivo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of patients with complete healing of their VLU
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Compare reduction of VLU wound area (absolute and relative).
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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
Prazo: 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.
Prazo: 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
Prazo: 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.
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Molnlycke Health Care AB

Colaboradores

Euraxi Pharma

Investigadores

  • Diretor de estudo: Arne Böhling, Mölnlycke Health Care AB

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de maio de 2026

Conclusão Primária (Estimado)

1 de maio de 2028

Conclusão do estudo (Estimado)

1 de maio de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

30 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de maio de 2026

Primeira postagem (Real)

20 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • The Boa Clinical Investigation

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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