RecruitingNot ApplicableNCT05608317

A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing

A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Venous Leg Ulcers Using a Non-Bordered Foam Dressing


Sponsor

Molnlycke Health Care AB

Enrollment

20 participants

Start Date

Nov 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. 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 the 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 venous leg ulcers (long-lasting wounds on the lower leg caused by poor vein circulation) who are treated with a specific non-bordered foam dressing. Researchers want to see how well this dressing manages wound fluid and supports healing. You may be eligible if: - You are 18 or older - You have been diagnosed with a chronic, exuding venous leg ulcer - Your wound produces moderate to large amounts of fluid - Your wound is between 3 cm² and 30 cm² in size - You have an ankle-brachial pressure index (ABPI) above 0.7 within the past 3 months - You are willing to use compression therapy You may NOT be eligible if: - Your wound is infected and requires systemic antibiotics at the time of enrollment - Your wound goes all the way around the leg (circumferential) - You have an allergy to the dressing material - You are currently using wound fillers 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

DEVICEALLEVYN Non-Adhesive

ALLEVYN Non-Adhesive combines patient comfort with the tri-layer fluid management system that enables moist wound healing. It utilizes a unique triple action technology that manages fluid to maintain optimal moist wound healing conditions. It is ideal for fragile and sensitive skin due to its non-adherent wound contact layer and soft and conformable construction. ALLEVYN Non-Adhesive consists of the following layers: * Breathable top film * Highly absorbent foam core * Non-adhesive wound contact layer


Locations(3)

Center for Clinical Trials, Inc.

San Francisco, 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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NCT05608317


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