Compression Bandages, Venous Leg Ulcer (VLU)
Conditions
Brief summary
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
Interventions
DEVICECompression 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.
DEVICECompression 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.
DEVICEWound Dressing Material
Appropriate primary wound dressing applied prior to compression therapy according to standard of care.
Sponsors
Molnlycke Health Care AB
Euraxi Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with complete healing of their VLU | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare reduction of VLU wound area (absolute and relative). | 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 . |
| Compare proportions of participants reaching 40% wound area reduction 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) | Proportion of participants reaching ≥40% relative wound area reduction (RWAR) at 4 weeks |
| Compare time to complete wound healing | 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. |
| Compare quality-of-life during treatment and up to 12 weeks. | 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. |
| Compare comfort and usability as rated by the participant | 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. |
| Compare usability as rated by the healthcare professional. | 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. |
| Compare device use including frequency of change | 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 |
| Compare safety profiles of both bandages. | 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. |
Countries
France
Contacts
CONTACTClinical Project Manager
STUDY_DIRECTORArne Böhling
Mölnlycke Health Care AB
Outcome results
None listed