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

RecruitingNAAges 18 Years - anyAllMolnlycke Health Care AB
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Signed consent to participate (including consent for digital imaging) * Adult aged โ‰ฅ18 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 โ‰ฅ1 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
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What it tests

  • Mepilex Up
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Where

4 sites
Center for Clinical Research, Inc.
Castro Valley, United States
Felix Sigal, DPM
Los Angeles, United States
University of Miami
Miami, United States
Serena Group Research Institute
Pittsburgh, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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