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

• Compression bandage system (Mepi™ Press 2) (Device): 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.
• Compression bandage system (UrgoK2®) (Device): 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.
• Wound Dressing Material (Device): Appropriate primary wound dressing applied prior to compression therapy according to standard of care.

Primary outcomes

• 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 outcomes

• 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.

Sex: All, ages: 18 Years to any

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.-

• Arne Böhling, Study director, Mölnlycke Health Care AB