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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Injury wounds
Secondary study objectives
Change in exudate amount over time
Change in exudate nature over time
Change in granulation tissue over time
+21 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
56 Previous Clinical Trials
7,924 Total Patients Enrolled
Hadar Lev-Tov, MD, MASPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
177 Total Patients Enrolled

Media Library

ALLEVYN Non-Adhesive (Foam Dressing) Clinical Trial Eligibility Overview. Trial Name: NCT05608317 — N/A
Venous Leg Ulcer Research Study Groups: Supportive Care with Non-Bordered Foam Dressing
Venous Leg Ulcer Clinical Trial 2023: ALLEVYN Non-Adhesive Highlights & Side Effects. Trial Name: NCT05608317 — N/A
ALLEVYN Non-Adhesive (Foam Dressing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05608317 — N/A
~6 spots leftby Jan 2026
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