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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
Diagnosed with a chronic, exuding VLU or DFU
Wound size from 3 cm2 to 30 cm2 for VLU and ≥1 cm2 for DFU, as determined by the clinician
Must not have
Circumferential wound
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a maximum total treatment period of 44 days or until healed, whichever occurs first.
Awards & highlights
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 belowSelect...
I have a long-lasting, leaking wound from a venous leg ulcer or diabetic foot ulcer.
Select...
My wound size fits the specified range for treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a wound that goes all the way around a part of my body.
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.
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 moreTrial 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.
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Who is running the clinical trial?
Molnlycke Health Care ABLead Sponsor
55 Previous Clinical Trials
7,777 Total Patients Enrolled
Hadar Lev-Tov, MD, MASPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
129 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a wound that needs antibiotics according to my doctor.People taking part in the DIPLO NBF study.I have a wound that goes all the way around a part of my body.My wound size fits the specified range for treatment.For participants with venous leg ulcers, the ankle-brachial pressure index (ABPI) should be between 0.7 and 1.4. If the ABPI is greater than 1.4, a measurement of the pressure in the big toe should be over 60 mmHg, or another test confirming normal blood flow in the lower leg is needed.You have used wound fillers.There is a moderate to large amount of fluid buildup.I am 18 years old or older.I have a long-lasting, leaking wound from a venous leg ulcer or diabetic foot ulcer.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive Care with Mepilex Up
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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