RecruitingNot ApplicableNCT05588583

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


Sponsor

Molnlycke Health Care AB

Enrollment

68 participants

Start Date

Oct 31, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study follows patients with chronic leg wounds — specifically venous leg ulcers (VLU) or diabetic foot ulcers (DFU) — that produce moderate to large amounts of fluid, to see how well a foam dressing called Mepilex Up helps manage the wound and promote healing over time. You may be eligible if: - You are 18 years of age or older - You have a chronic, draining venous leg ulcer or diabetic foot ulcer - Your wound produces a moderate to large amount of fluid - Your wound is within the required size range (3–30 cm² for venous leg ulcers; ≥1 cm² for diabetic foot ulcers) - You are willing to use compression therapy if you have a venous leg ulcer You may NOT be eligible if: - Your ulcer is currently infected and requires antibiotics - Your wound goes all the way around the limb (circumferential) - You have a known allergy to the dressing materials - You are already enrolled in the DIPLO NBF study - You are currently using wound filler products Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMepilex 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

View Full Details on ClinicalTrials.gov

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NCT05588583


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