NCT00301496

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2006

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

First QC Date

March 10, 2006

Last Update Submit

September 30, 2024

Conditions

Venous Ulcer

Outcome Measures

Primary Outcomes (1)

  • Product Performance

Interventions

Coban 2 Layer Compression SystemDEVICE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • venous leg ulcer
  • patient can walk

You may not qualify if:

  • cancerous ulcers
  • diabetic foot ulcer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Institute for Advanced Wound Care

Montgomery, Alabama, 36111, United States

Location

Center for Clinical Research, Inc.

Castro Valley, California, 94546, United States

Location

Gwinnet Hospital System

Lawrenceville, Georgia, 30045, United States

Location

Wound Healing and Treatment Center - Silver Cross Hospital

Joliet, Illinois, 60432, United States

Location

Wound Healing Center

Terre Haute, Indiana, 47807, United States

Location

Dermatology Clinic - Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Dermatology Clinic

Mississauga, Ontario, L4Y 1A6, Canada

Location

Wound Healing Research Unit

Cardiff, United Kingdom

Location

Grantham & District Hospital

Grantham, United Kingdom

Location

Clayponds Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Christine Moffatt, PhD, MA, RGN

    Centre for Research and Implementation of Clinical Practice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 10, 2006

First Posted

March 13, 2006

Study Start

March 1, 2006

Study Completion

April 1, 2007

Last Updated

October 2, 2024

Record last verified: 2024-09

Locations

US(5)CA(2)GB(3)