A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers
2026년 5월 13일 업데이트: 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
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
386
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Clinical Project Manager
- 전화번호: +46 (0)31- 722 31 96
- 이메일: kristina.welinder@molnlycke.com
연구 장소
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Castelnau-le-Lez, 프랑스
- Clinique du Parc-Montpellier
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연락하다:
- Principal Investigator
- 전화번호: +33 4 67 33 13 31
- 이메일: c-geri@chu-montpellier.fr
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Grenoble, 프랑스
- CHU Michallon Grenoble
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연락하다:
- Coordinating Principal Investigator
- 전화번호: +33 (0)4 76 76 75 75
- 이메일: sblaise@chu-grenoble.fr
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Lyon, 프랑스
- Clinique du Parc Lyon
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연락하다:
- Principal Investigator
- 전화번호: +33 4 49 44 00 90
- 이메일: centreplaieslyon@protonmail.com
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Lyon, 프랑스
- Hopital Edouard Herriot_HCL
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연락하다:
- Principal Investigator
- 전화번호: +33 4 72 11 80 88
- 이메일: judith.catella@chu-lyon.fr
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Nantes, 프랑스
- CHU Nantes
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연락하다:
- Principal Investigator
- 전화번호: +33 2 40 08 33 33
- 이메일: cecile.durant@chu-nantes.fr
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Poitiers, 프랑스
- Poitiers Polyclinique
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연락하다:
- Principal Investigator
- 전화번호: +33 5 49 61 70 00
- 이메일: dr.kassab@pdp86.fr
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Toulouse, 프랑스
- CHU Toulouse/Hopital Rangueil
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연락하다:
- Principal Investigator
- 전화번호: +33 5 61 77 22 33
- 이메일: malloizel-delaunay.j@chu-toulouse.fr
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Toulouse, 프랑스
- Clinique Pasteur-Toulouse
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연락하다:
- Principal Investigator
- 전화번호: +33 5 62 21 31 31
- 이메일: pleger@clinique-pasteur.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.-
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
Appropriate primary wound dressing applied prior to compression therapy according to standard of care.
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활성 비교기: 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.
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Appropriate primary wound dressing applied prior to compression therapy according to standard of care.
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of patients with complete healing of their VLU
기간: 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
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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.
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Compare reduction of VLU wound area (absolute and relative).
기간: 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
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Absolute and percentage VLU wound surface area reduction compared to baseline at all follow-up visits .
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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
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Compare proportions of participants reaching 40% wound area reduction at 4 weeks
기간: 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)
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Proportion of participants reaching ≥40% relative wound area reduction (RWAR) at 4 weeks
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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)
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Compare time to complete wound healing
기간: 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
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Time to wound healed in each cohort, for patients with healed wound at termination.
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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
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Compare quality-of-life during treatment and up to 12 weeks.
기간: 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
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Quality of Life assessed with Wound-QoL-17 tool at each visit and change compared to baseline.
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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
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Compare comfort and usability as rated by the participant
기간: 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
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At each follow-up visit, participants will complete a usability questionnaire including Likert scale assessments.
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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
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Compare usability as rated by the healthcare professional.
기간: 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
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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.
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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
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Compare device use including frequency of change
기간: 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
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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
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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
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Compare safety profiles of both bandages.
기간: 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
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A(D)E and SA(D)E and DD rates.
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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
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연구 기록 날짜
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연구 주요 날짜
연구 시작 (추정된)
2026년 5월 1일
기본 완료 (추정된)
2028년 5월 1일
연구 완료 (추정된)
2028년 5월 1일
연구 등록 날짜
최초 제출
2026년 4월 30일
QC 기준을 충족하는 최초 제출
2026년 5월 13일
처음 게시됨 (실제)
2026년 5월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 13일
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2026년 5월 1일
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