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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Mepilex Up

Mepilex Up is a highly conformable dressing that absorbs both low and high viscous exudates, maintains a moist wound environment and minimises the risk of maceration. The dressing has a Safetac® wound contact layer that is a unique adhesive technology. It minimises pain to patients and trauma to wounds and the surrounding skin at dressing removal. Mepilex Up consists of: * a soft silicone wound contact layer (Safetac) * a flexible absorbent pad of compressed polyurethane foam * an outer polyurethane film which is breathable but waterproof Dressing material content: Silicone, polyurethane

Locations (4)

Center for Clinical Research, Inc.
Castro Valley, California, United States
Felix Sigal, DPM
Los Angeles, California, United States
University of Miami
Miami, Florida, United States
Serena Group Research Institute
Pittsburgh, Pennsylvania, United States