ALLEVYN Non-Adhesive Dressing for Venous Leg Ulcers

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byHadar Lev-Tov, MD, MAS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Molnlycke Health Care AB

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Hadar Lev-Tov, MD, MAS

Principal Investigator

University of Miami

Eligibility Criteria

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.

Inclusion Criteria

You are 18 years old or older.

You have a long-lasting wound that constantly releases fluid.

There is a moderate to large amount of fluid coming from the body.

See 4 more

Exclusion Criteria

You have an infected wound that needs antibiotics.

Known allergy/hypersensitivity to the materials of the dressing

You have a wound that goes all the way around something, like a limb.

See 2 more

Treatment Details

Interventions

ALLEVYN Non-Adhesive (Foam Dressing)

Trial OverviewThe 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.

Participant Groups

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.