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Study of Mepilex Up for Chronic Wounds

This study is looking at how well a special absorbent dressing called Mepilex Up helps chronic wounds heal. These wounds include venous leg ulcers (open sores on the leg due to poor blood flow) and diabetic foot ulcers (open sores on the foot due to diabetes). Researchers want to see how the wounds change over time while using Mepilex Up. You might be able to join if you are an adult with one of these types of wounds, and your wound has a moderate to large amount of fluid (exudate). Your wound also needs to be a certain size. The study aims to enroll 68 participants. The current status of the study is unclear, so it's not known if they are actively enrolling.

Study design
This study is an open-label (meaning you and the doctors will know what treatment you are receiving) investigation that will follow 68 participants with chronic wounds.
What's involved
You would wear the Mepilex Up dressing for up to 6 weeks or until your wound heals, changing it weekly. You will have 7 visits to the study site over this period to check your wound and overall well-being.
Compensation
Not stated in the trial record.
Follow-up
Your wound progress will be followed from your first visit until your last follow-up visit, for a maximum of 44 days or until your wound heals.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05588583

A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.

Recruiting
NAAges 18+InterventionalSupportive care
Molnlycke Health Care AB
~68 participants
Updated 2023-04-20 on ClinicalTrials.gov
What's tested:Mepilex Up

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Wound progress of the total effect of treatment using Mepilex Up
Measured over From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.

Conditions

Wounds
Wound of Skin
Wound Leg
Wound; Foot
Diabetic Foot Ulcer
Venous Leg Ulcer

Explore related trials

Diabetic foot ulcerStasis ulcer

Where it's being run

4 sites across 3 states
California2
Florida1
Pennsylvania1

Study leadership

  • Hadar Lev-Tov, MD, MAS · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Janet Kandrevas, MD, MS
[email protected]
734-358-2174
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Signed consent to participate (including consent for digital imaging)
Adult aged ≥18 years
Diagnosed with a chronic, exuding VLU or DFU
Exudate amount moderate to large
Wound size from 3 cm2 to 30 cm2 for VLU and ≥1 cm2 for DFU, as determined by the clinician
For VLU: ABPI (within 3 months) \> 0.7. If ABPI \> 1.4, then big toe pressure \> 60 mmHg is required or an alternative measurement verifying normal distal arterial flow
For VLU: Willing to be compliant with compression therapy

Exclusion

Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at enrollment
Circumferential wound
Known allergy/hypersensitivity to the materials of the dressing
Patients participating in the DIPLO NBF study
Use of wound fillers

What this trial measures

  • Wound progress of the total effect of treatment using Mepilex UpFrom baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.

    Wound progress is the total effect of treatment using Mepilex Up as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition by the treating investigator/designee. Wound progress will be assessed as deteriorated, no change, improved, or healed at each visit. Wound area will be measured by an independent evaluator assisted by digital software at each visit and recorded as cm2 using the formula, A= π\*L\*W/4.