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A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
About the study
The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit.
Participants will be asked to wear Mepilex Up dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.
What is being tested
- Mepilex Up (device)
Sponsor: Molnlycke Health Care AB · Participants: 68 · Started: Oct 31, 2022
Contact the study team
- Janet Kandrevas, MD, MS · Phone: 734-358-2174
- Andrea Picchietti, MS, CCRA · Phone: 260-258-3879
Official record on ClinicalTrials.gov — NCT05588583
Locations in the U.S.
| California | Center for Clinical Research, Inc., Castro Valley Felix Sigal, DPM, Los Angeles |
| Florida | University of Miami, Miami |
| Pennsylvania | Serena Group Research Institute, Pittsburgh |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.