A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing

Description

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.

Conditions

Wounds, Wound of Skin, Wound Leg, Venous Leg Ulcer

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Study Overview

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Study Details

Study overview

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.

A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Venous Leg Ulcers Using a Non-Bordered Foam Dressing

A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing

Condition
Wounds
Intervention / Treatment

-

Contacts and Locations

San Francisco

Center for Clinical Trials, Inc., San Francisco, California, United States, 94115

Miami

University of Miami, Miami, Florida, United States, 33125

Pittsburgh

Serena Group Research Institute, Pittsburgh, Pennsylvania, United States, 15222

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Signed consent to participate (including consent for digital imaging)
  • * Adult aged ≥18 years
  • * Diagnosed with a chronic, exuding VLU
  • * Exudate amount moderate to large
  • * Wound size from 3 cm2 to 30 cm2, as determined by the clinician
  • * ABPI (within 3 months) \> 0.7. If ABPI \> 1.4, then big toe pressure \> 60 mmHg is required or an alternative measurement verifying normal distal arterial flow
  • * Willing to be compliant with compression therapy
  • * Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at enrollment
  • * Circumferential wound
  • * Known allergy/hypersensitivity to the materials of the dressing
  • * Use of wound fillers

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Molnlycke Health Care AB,

Hadar Lev-Tov, MD, MAS, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

2024-11-30