Leg UlcerNCT07782008
Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears
A study testing Mepilex® Up in people with Leg Ulcer and Pressure Ulcer (PU), run by Molnlycke Health Care AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcer, Pressure Ulcer (PU), Skin Tears
- What is being tested?
- Mepilex® Up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- 31 Aug 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Adults aged ≥18 years
- Exudate levels moderate to high
- Wound sizes:
- Leg ulcers: between 3 cm² and 30 cm²
- Foot ulcers: ≥0,75 cm²
- Skin tears: between 3 cm² and 30 cm²
- Pressure ulcers: Foot ulcer caused by pressure
Who cannot join
- Circumferential ulcer
- Known allergy/hypersensitivity to the materials of the dressings or products
- Use of wound fillers
- Infected ulcer/wound, defined as any wound condition requiring the prescription or continuation of systemic antibiotics (orally or parental) at enrolment
- 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
- Woman of childbearing potential, who is pregnant or breastfeeding or plans on becoming pregnant during the investigation period
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Forsåker Vårdcentral
Mölndal, Västra Götaland County, 43133
Joel Ellbin, MD
About this study
Official title: An Open, Non-Comparative, Multi-Center Clinical Investigation to Confirm Performance and Safety of Mepilex® Up When Used on Ulcers and Skin Tears on Leg and Foot
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.
Read the detailed description
This prospective, open-label, multicenter, post-market clinical follow-up investigation will evaluate Mepilex® Up used as the primary absorbent dressing in the treatment of exuding ulcers and skin tears located on the leg and foot. Approximately 70 adult participants will be enrolled and followed for up to 6 weeks or until wound healing, whichever occurs first. Assessments include wound progression, wound healing, wound area reduction, peri-wound skin condition, dressing performance, participant-reported pain, and safety outcomes. Treatment and wound care procedures will follow local standard clinical practice.
- Conditions
- Leg Ulcer, Pressure Ulcer (PU), Skin Tears, Foot Ulcer, Diabetic Foot Ulcer
- Being tested
- Mepilex® Up
- Keywords
- MepilexUp, PMCF Clinical Investigation, Wound Healing, Exuding Wounds
- Medical subject headings
- Leg Ulcer, Pressure Ulcer, Foot Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex® UpDevice
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 group | Role | What they receive |
|---|---|---|
| Mepilex® Up | Experimental | Participants 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. Receives: Device: Mepilex® Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound progress towards healing
Assessment of wound progress compared with the previous visit and classified as Deteriorated, no change, improved, or healed.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start31 Aug 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants receive treatment with Mepilex® Up. There is no comparator group.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782008
- Sponsor's protocol ID
- Zebra
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non-Comparative, Multi-Center Clinical Investigation to Confirm Performance and Safety of Mepilex® Up When Used on Ulcers and Skin Tears on Leg and Foot
- ClinicalTrials.gov ID
- NCT07782008
- Acronym / sponsor ID
- Zebra
- Conditions
- Leg Ulcer, Pressure Ulcer (PU), Skin Tears, Foot Ulcer, Diabetic Foot Ulcer
- Keywords
- MepilexUp, PMCF Clinical Investigation, Wound Healing, Exuding Wounds
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, open-label, multicenter, post-market clinical follow-up investigation will evaluate Mepilex® Up used as the primary absorbent dressing in the treatment of exuding ulcers and skin tears located on the leg and foot. Approximately 70 adult participants will be enrolled and followed for up to 6 weeks or until wound healing, whichever occurs first. Assessments include wound progression, wound healing, wound area reduction, peri-wound skin condition, dressing performance, participant-reported pain, and safety outcomes. Treatment and wound care procedures will follow local standard clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants receive treatment with Mepilex® Up. There is no comparator group.
| Arm | Type | Receives |
|---|---|---|
| Mepilex® Up | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent.
- Adults aged ≥18 years
- Exudate levels moderate to high
- Wound sizes:
- Pressure ulcers: Foot ulcer caused by pressure
Key exclusion criteria (7 listed)
- Circumferential ulcer
- Known allergy/hypersensitivity to the materials of the dressings or products
- Use of wound fillers
- Infected ulcer/wound, defined as any wound condition requiring the prescription or continuation of systemic antibiotics (orally or parental) at enrolment
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mepilex® UpMepilex® 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. | Device | Mepilex® Up |
Primary outcome
Wound progress towards healing
Time frame: Up to 6 weeks
Assessment of wound progress compared with the previous visit and classified as Deteriorated, no change, improved, or healed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
Related trials for Leg Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepilex® Up in people with Leg Ulcer and Pressure Ulcer (PU), run by Molnlycke Health Care AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Sundh, Ph.D. (+460739412816, daniel.sundh@molnlycke.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound progress towards healing (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.