Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears
- Sponsor
- Molnlycke Health Care AB
- Study ID
- NCT07782008
- Status
- Not Yet Recruiting
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Conditions
- Diabetic Foot Ulcer
- Foot Ulcer
- Leg Ulcer
- Pressure Ulcer (PU)
- Skin Tears
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Mepilex® Up — DEVICEMepilex® Up is a soft silicone foam dressing intended for the management of exuding wounds. The dressing is used as the primary absorbent dressing throughout the investigation according to its instructions for use and local standard clinical practice.
Study Details
This post-market clinical follow-up investigation is designed to evaluate the performance and safety of Mepilex® Up when used for the management of exuding ulcers and skin tears on the leg and foot. Approximately 70 adult participants will be treated with Mepilex® Up and followed for up to 6 weeks to assess wound progression and safety.
Key Dates
- First listed
- Aug 24, 2026
- Start date
- Aug 31, 2026
- Status verified
- Aug 2026
- Primary completion
- Jun 30, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 70 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Mepilex® UpParticipants receive treatment with Mepilex® Up as the primary absorbent dressing for up to 6 weeks or until wound healing. Wound care procedures follow local standard clinical practice.
Primary Outcome Measure
Wound progress towards healing [ Time Frame: Up to 6 weeks ]
Central Contacts
- Daniel Sundh, Ph.D.+460739412816
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