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

NCT ID: NCT00301496

Last Updated: 2024-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Venous Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Coban 2 Layer Compression System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* venous leg ulcer
* patient can walk

Exclusion Criteria

* cancerous ulcers
* diabetic foot ulcer
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

Solventum US LLC

INDUSTRY

Sponsor Role lead

Principal Investigators

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Christine Moffatt, PhD, MA, RGN

Role: PRINCIPAL_INVESTIGATOR

Centre for Research and Implementation of Clinical Practice

Locations

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Institute for Advanced Wound Care

Montgomery, Alabama, United States

Site Status

Center for Clinical Research, Inc.

Castro Valley, California, United States

Site Status

Gwinnet Hospital System

Lawrenceville, Georgia, United States

Site Status

Wound Healing and Treatment Center - Silver Cross Hospital

Joliet, Illinois, United States

Site Status

Wound Healing Center

Terre Haute, Indiana, United States

Site Status

Dermatology Clinic - Montreal General Hospital

Montreal, Quebec, Canada

Site Status

Dermatology Clinic

Mississauga, Ontario, , Canada

Site Status

Wound Healing Research Unit

Cardiff, , United Kingdom

Site Status

Grantham & District Hospital

Grantham, , United Kingdom

Site Status

Clayponds Hospital

London, , United Kingdom

Site Status

Countries

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United States Canada United Kingdom

Other Identifiers

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05-010302

Identifier Type: -

Identifier Source: org_study_id

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