Randomized Controlled 8-week Crossover Evaluation of Compression Bandage Systems for Venous Leg Ulcers

September 30, 2024 updated by: Solventum US LLC

Randomized Controlled Eight Week Cross-over Clinical Evaluation of the 3M Coban 2-Layer Compression System to Evaluate the Product Performance in Patients With Venous Leg Ulcers

The purpose of this study is to evaluate the product performance of a new 2-layer compression bandage for the treatment of venous leg ulcers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the product performance of a new 2-layer compression bandage for the treatment of venous leg ulcers. The new bandage is a 2-layer compression system. It will be used over primary dressings to provide the compression that is beneficial to venous leg ulcers.

Study Type

Interventional

Enrollment

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Mississauga, Ontario, Canada, L4Y 1A6
        • Dermatology Clinic
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Dermatology Clinic - Montreal General Hospital
  • United Kingdom
      • Cardiff, United Kingdom
        • Wound Healing Research Unit
      • Grantham, United Kingdom
        • Grantham & District Hospital
      • London, United Kingdom
        • Clayponds Hospital
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36111
        • Institute for Advanced Wound Care
    • California
      • Castro Valley, California, United States, 94546
        • Center for Clinical Research, Inc.
    • Georgia
      • Lawrenceville, Georgia, United States, 30045
        • Gwinnet Hospital System
    • Illinois
      • Joliet, Illinois, United States, 60432
        • Wound Healing and Treatment Center - Silver Cross Hospital
    • Indiana
      • Terre Haute, Indiana, United States, 47807
        • Wound Healing Center

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.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • venous leg ulcer
  • patient can walk

Exclusion Criteria:

  • cancerous ulcers
  • diabetic foot ulcer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Product Performance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solventum US LLC

Collaborators

3M

Investigators

  • Principal Investigator: Christine Moffatt, PhD, MA, RGN, Centre for Research and Implementation of Clinical Practice

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 Major Dates

Study Start

March 1, 2006

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

March 10, 2006

First Submitted That Met QC Criteria

March 10, 2006

First Posted (Estimated)

March 13, 2006

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-010302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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