RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-11-08
Study Completion:2024-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05608317

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed consent to participate (including consent for digital imaging)
  2. * Adult aged ≥18 years
  3. * Diagnosed with a chronic, exuding VLU
  4. * Exudate amount moderate to large
  5. * Wound size from 3 cm2 to 30 cm2, as determined by the clinician
  6. * 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
  7. * Willing to be compliant with compression therapy
  1. * 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
  2. * Circumferential wound
  3. * Known allergy/hypersensitivity to the materials of the dressing
  4. * Use of wound fillers

Contacts and Locations

Study Contact

Janet Kandrevas, MD, MS
CONTACT
734-358-2174
janet.kandrevas@molnlycke.com
Andrea Picchietti, MS, CCRA
CONTACT
260-258-3879
andrea.picchietti@molnlycke.com

Principal Investigator

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

Study Locations (Sites)

Center for Clinical Trials, Inc.
San Francisco, California, 94115
United States
University of Miami
Miami, Florida, 33125
United States
Serena Group Research Institute
Pittsburgh, Pennsylvania, 15222
United States

Collaborators and Investigators

Sponsor: Molnlycke Health Care AB

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-08
Study Completion Date2024-11-30

Study Record Updates

Study Start Date2022-11-08
Study Completion Date2024-11-30

Terms related to this study

Keywords Provided by Researchers

  • Venous Leg Ulcer

Additional Relevant MeSH Terms

  • Wounds
  • Wound of Skin
  • Wound Leg
  • Venous Leg Ulcer