Ireland
--:--IST
Starting soon Not applicable

Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears

NCT07782008 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2026-08-31
Last updated
2026-08-26

Condition(s) studied

Leg UlcerPressure Ulcer (PU)Skin TearsFoot UlcerDiabetic Foot Ulcer

Investigational drug(s) / intervention(s)

Mepilex® Up

Mepilex® Up: Mepilex® 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 summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Signed informed consent. 2. Adults aged ≥18 years 3. Exudate levels moderate to high 4. Wound sizes: 1. Leg ulcers: between 3 cm² and 30 cm² 2. Foot ulcers: ≥0,75 cm² 3. Skin tears: between 3 cm² and 30 cm² 5. Pressure ulcers: Foot ulcer caused by pressure Exclusion Criteria: 1. Circumferential ulcer 2. Known allergy/hypersensitivity to the materials of the dressings or products 3. Use of wound fillers 4. Infected ulcer/wound, defined as any wound condition requiring the prescription or continuation of systemic antibiotics (orally or parental) at enrolment 5. Participating in ongoing clinical investigations, or during the past 30 days, which may impact the outcome of this investigation based on the judgement of the investigator 6. Woman of childbearing potential, who is pregnant or breastfeeding or plans on becoming pregnant during the investigation period 7. Not willing or able to comply to clinical investigation procedures, or not suitable for participation according to the investigator (e.g., alcohol or substance abuse)

Primary outcome measure(s)

  • Wound progress towards healing — Up to 6 weeks
    Assessment of wound progress compared with the previous visit and classified as Deteriorated, no change, improved, or healed.

Trial sites (1)

FacilityCityRegionStatus
Forsåker Vårdcentral Mölndal Västra Götaland County
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07782008 on ClinicalTrials.gov ↗ ← All trials in Sweden