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

Primary Purpose

Venous Ulcer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Coban 2 Layer Compression System
Sponsored by
3M
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Ulcer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: venous leg ulcer patient can walk Exclusion Criteria: cancerous ulcers diabetic foot ulcer

Sites / Locations

  • Institute for Advanced Wound Care
  • Center for Clinical Research, Inc.
  • Gwinnet Hospital System
  • Wound Healing and Treatment Center - Silver Cross Hospital
  • Wound Healing Center
  • Dermatology Clinic - Montreal General Hospital
  • Dermatology Clinic
  • Wound Healing Research Unit
  • Grantham & District Hospital
  • Clayponds Hospital

Outcomes

Primary Outcome Measures

Product Performance

Secondary Outcome Measures

Full Information

First Posted
March 10, 2006
Last Updated
October 10, 2007
Sponsor
3M
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1. Study Identification

Unique Protocol Identification Number
NCT00301496
Brief Title
Randomized Controlled 8-Week Crossover Evaluation of Compression Bandage Systems for Venous Leg Ulcers
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
3M

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Coban 2 Layer Compression System
Primary Outcome Measure Information:
Title
Product Performance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: venous leg ulcer patient can walk Exclusion Criteria: cancerous ulcers diabetic foot ulcer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Moffatt, PhD, MA, RGN
Organizational Affiliation
Centre for Research and Implementation of Clinical Practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Advanced Wound Care
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111
Country
United States
Facility Name
Center for Clinical Research, Inc.
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Gwinnet Hospital System
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Wound Healing and Treatment Center - Silver Cross Hospital
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60432
Country
United States
Facility Name
Wound Healing Center
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47807
Country
United States
Facility Name
Dermatology Clinic - Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Dermatology Clinic
City
Mississauga, Ontario
ZIP/Postal Code
L4Y 1A6
Country
Canada
Facility Name
Wound Healing Research Unit
City
Cardiff
Country
United Kingdom
Facility Name
Grantham & District Hospital
City
Grantham
Country
United Kingdom
Facility Name
Clayponds Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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