Venous UlcerNCT00301496
Randomized Controlled 8-week Crossover Evaluation of Compression Bandage Systems for Venous Leg Ulcers
A study testing Coban 2 Layer Compression System in people with Venous Ulcer, run by Solventum US LLC at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Venous Ulcer
- What is being tested?
- Coban 2 Layer Compression System
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Mar 2006to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- venous leg ulcer
- patient can walk
Who cannot join
- cancerous ulcers
- diabetic foot ulcer
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States5 sites
Center for Clinical Research, Inc.
Castro Valley, California, 94546
Wound Healing and Treatment Center - Silver Cross Hospital
Joliet, Illinois, 60432
Gwinnet Hospital System
Lawrenceville, Georgia, 30045
Institute for Advanced Wound Care
Montgomery, Alabama, 36111
Wound Healing Center
Terre Haute, Indiana, 47807
United Kingdom3 sites
Wound Healing Research Unit
Cardiff
Grantham & District Hospital
Grantham
Clayponds Hospital
London
Canada2 sites
Dermatology Clinic
Mississauga, Ontario, L4Y 1A6
Dermatology Clinic - Montreal General Hospital
Montreal, Quebec, H3G 1A4
About this study
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
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.
Read the 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.
- Conditions
- Venous Ulcer
- Being tested
- Coban 2 Layer Compression System
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coban 2 Layer Compression SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Product Performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2006 (estimated)
- Study startMar 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Investigators
- Christine Moffatt, PhD, MA, RGN, Principal investigator, Centre for Research and Implementation of Clinical Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301496
- Sponsor's protocol ID
- 05-010302
- Status last verified
- Sep 2024
- First submitted
- 10 Mar 2006
- Last updated
- 2 Oct 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00301496
- Acronym / sponsor ID
- 05-010302
- Conditions
- Venous Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Mar 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 13 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- venous leg ulcer
- patient can walk
Key exclusion criteria (2 listed)
- cancerous ulcers
- diabetic foot ulcer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coban 2 Layer Compression System | Device | – |
Primary outcome
Product Performance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Moffatt, PhD, MA, RGN principal investigator
Centre for Research and Implementation of Clinical Practice
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coban 2 Layer Compression System in people with Venous Ulcer, run by Solventum US LLC at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Product Performance. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.