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Foam Dressing
ALLEVYN Non-Adhesive Dressing for Venous Leg Ulcers
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
Be older than 18 years old
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 studies the effectiveness of a special foam dressing in healing chronic leg ulcer wounds. Patients wear it for up to 6 weeks to see the progress of healing.
Who is the study for?
This trial is for adults over 18 with chronic, oozing venous leg ulcers. Eligible participants should have moderate to large wound exudate and a wound size between 3 cm2 to 30 cm2. They must not have an infected ulcer, known allergies to the dressing material, a wrap-around wound, or be in another specific study. Participants need normal blood flow as verified by certain pressure measurements and agree to compression therapy.Check my eligibility
What is being tested?
The trial is testing ALLEVYN Non-Adhesive dressings on individuals with chronic venous leg ulcers. The focus is on tracking healing progress over time up to six weeks or until the wound heals. Dressings will be changed weekly.See study design
What are the potential side effects?
Potential side effects may include skin irritation or allergic reactions related to the non-bordered foam dressing materials used in this clinical investigation.
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
+21 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Supportive Care with Non-Bordered Foam DressingExperimental Treatment1 Intervention
All Subjects will use a non-bordered foam dressing as the absorbent primary dressing.
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Who is running the clinical trial?
Molnlycke Health Care ABLead Sponsor
55 Previous Clinical Trials
7,825 Total Patients Enrolled
Hadar Lev-Tov, MD, MASPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
177 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are 18 years old or older.You have an infected wound that needs antibiotics.You have a wound that goes all the way around something, like a limb.You have a long-lasting wound that constantly releases fluid.People who are taking part in the DIPLO01 study.You have used any type of wound fillers.There is a moderate to large amount of fluid coming from the body.You have a wound size between 3 square centimeters and 30 square centimeters, as determined by the doctor.Your ankle-brachial pressure index (ABPI) should be between 0.7 and 1.4. If it's over 1.4, your big toe pressure should be over 60 mmHg, or another test should show that blood flow in your legs is normal.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive Care with Non-Bordered Foam Dressing
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacant roles in this research endeavor for participants?
"Clinicaltrials.gov data indicates that this clinical trial is no longer actively recruiting participants. This research was initially posted on November 8th 2022 and last edited on the first of November in the same year, but luckily there are 1,088 other trials currently open for enrolment."
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