A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMolnlycke Health Care AB
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Mepilex Up
Treatment groups
68 Participants
are divided into 1 treatment groupLocations
4Center for Clinical Research, Inc.94546, Castro ValleyCalifornia, United States
Felix Sigal, DPM90010, Los AngelesCalifornia, United States
University of Miami33125, MiamiFlorida, United States
Serena Group Research Institute15222, PittsburghPennsylvania, United States
Sponsors and collaborators
Molnlycke Health Care AB
Lead sponsor
Source ClinicalTrials.gov