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Absorbent Dressing

Mepilex Up Dressing for Chronic Wounds

N/A

Recruiting

Led By Hadar Lev-Tov, MD, MAS

Research Sponsored by Molnlycke Health Care AB

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult aged ≥18 years

Diagnosed with a chronic, exuding VLU or DFU

Timeline

Screening 3 weeks

Treatment Varies

Follow Up a maximum total treatment period of 44 days or until healed, whichever occurs first.

Awards & highlights

Study Summary

This trial will monitor the progress of wounds in people with venous or diabetic ulcers while they use Mepilex Up dressing to see how it helps them heal over time.

Who is the study for?

This trial is for adults over 18 with chronic, oozing wounds from diabetic foot ulcers or venous leg ulcers. Participants should have a wound size between 3 to 30 cm2 and be willing to use compression therapy if needed. They must not have an infected ulcer, allergy to dressing materials, or be in another wound study.Check my eligibility

What is being tested?

The trial tests Mepilex Up, an absorbent dressing on patients with venous leg and diabetic foot ulcers. It aims to track the healing progress of these wounds over up to six weeks or until healed, changing dressings weekly.See study design

What are the potential side effects?

Potential side effects may include skin irritation or allergic reactions due to the materials in Mepilex Up dressing. However, since it's a non-invasive treatment, severe side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a long-lasting, leaking wound from a venous leg ulcer or diabetic foot ulcer.

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My wound size fits the specified range for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ a maximum total treatment period of 44 days or until healed, whichever occurs first.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~a maximum total treatment period of 44 days or until healed, whichever occurs first.

This trial's timeline: 3 weeks for screening, Varies for treatment, and a maximum total treatment period of 44 days or until healed, whichever occurs first. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Injury wounds

Secondary outcome measures

Change in exudate amount over time

Change in exudate nature over time

Change in granulation tissue over time

+25 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive Care with Mepilex UpExperimental Treatment1 Intervention

All Subjects will use a soft, silicone, non-bordered, adhesive, foam dressing called Mepilex Up as the absorbent primary dressing.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Molnlycke Health Care ABLead Sponsor

54 Previous Clinical Trials

7,757 Total Patients Enrolled

Hadar Lev-Tov, MD, MASPrincipal InvestigatorUniversity of Miami

2 Previous Clinical Trials

129 Total Patients Enrolled

Media Library

Mepilex Up (Absorbent Dressing) Clinical Trial Eligibility Overview. Trial Name: NCT05588583 — N/A

Venous Leg Ulcer Research Study Groups: Supportive Care with Mepilex Up

Venous Leg Ulcer Clinical Trial 2023: Mepilex Up Highlights & Side Effects. Trial Name: NCT05588583 — N/A

Mepilex Up (Absorbent Dressing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05588583 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scale of this research investigation?

"Affirmative. According to clinicaltrials.gov, this research protocol is currently recruiting participants; it was posted on October 31st 2022 and revised on November 7th of the same year. The study has room for 68 enrollees between two sites."

Answered by AI

Does this research currently have any room for new participants?

"As per the information available on clinicaltrials.gov, this research is currently recruiting individuals to take part in the trial. This study was publicly uploaded on October 31st 2022 and has since been revised on November 7th of that year."

Answered by AI

Recent research and studies

Journal of Pain and Symptom ManagementJournal

Studies Comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for Assessment of Pain Intensity in Adults: A Systematic Literature Review

Hjermstad, Marianne Jensen, Peter M. Fayers, Dagny F. Haugen, Augusto Caraceni, Geoffrey W. Hanks, Jon H. Loge, Robin Fainsinger, Nina Aass, and Stein Kaasa. 2011. “Studies Comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for Assessment of Pain Intensity in Adults: A Systematic Literature Review”. Journal of Pain and Symptom Management. Elsevier BV. doi:10.1016/j.jpainsymman.2010.08.016.

Wound Repair and RegenerationJournal

Validity and Feasibility of the Wound-qol Questionnaire on Health-related Quality of Life in Chronic Wounds

Augustin, Matthias, Elena Conde Montero, Nicole Zander, Katrin Baade, Katharina Herberger, E. Sebastian Debus, Holger Diener, Thomas Neubert, and Christine Blome. 2017. “Validity and Feasibility of the Wound-qol Questionnaire on Health-related Quality of Life in Chronic Wounds”. Wound Repair and Regeneration. Wiley. doi:10.1111/wrr.12583.

clinicaltrials.govStudy

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

2022. "A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05588583.