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

Summary

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

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

Conditions7

Locations4 sites

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