Varicose UlcerNCT02561013
A Clinical Study to Assess a Compression Device in Patients With Venous Leg Ulcers
A study testing 3M™ Coban™ Custom Fit Compression System and Profore in people with Varicose Ulcer, run by 3M at 5 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the product performance of a new adjustable compression system 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
- Varicose Ulcer
- What is being tested?
- 3M™ Coban™ Custom Fit Compression System and Profore
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2015to Mar 2016
- 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
- Is the subject 21 years or older?
- Does the subject have an active venous leg ulceration? If multiple ulcers are present, the investigator will need to select a single ulcer of the study leg that is > 2cm apart from any other ulcer?
- Does the subject have an ulcer size between 1cm2 and 12cm2?
- Does the subject have an ABPI between 0.8 and 1.3 that was taken within the past 28 days?
- Is the subject ambulatory?
- Is the subject or family member willing to self-manage the venous leg ulcer therapy at home in collaboration with the medical staff, including the ability to properly readjust the closure straps as indicated by tension indicators, and apply new dressings when needed?
- Is the subject able to understand questionnaire items and action items (e.g., Subject Diary)?
- Is the subject willing to give written informed consent, including permission to take photographs of the study leg?
Who cannot join
- Does the subject have severe arterial occlusive disease?
- Does the subject have decompensated heart insufficiency NYHA Class IV, ACC.AHA Stage D?
- Does the subject have septic phlebitis?
- Does the subject have severe deep vein thrombosis (phlegmasia cerulea dolens) and other conditions contraindicated according to established guidelines and local procedures?
- Does the subject have known hypersensitivity to any of the component materials?
- Does the subject have a suspected clinical infection of the ulcer or any other systemic infection (requiring antibiotics)?
Show all 13Show fewer
- Is the subject scheduled for surgery for the ulcer during the 12 weeks following inclusion?
- Does the subject have a hospital stay planned for the 12 weeks following inclusion?
- Does the subject have a suspected or confirmed cancerous ulceration?
- Does the subject have severe peripheral sensitive neuropathy?
- Is the subject participating in any other prospective study interfering with this study?
- Does the subject have any medical condition which in the professional opinion of the investigator disqualifies the subject from enrollment into the study?
- Does the subject have a history of noncompliance to therapies?
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
Institute for Advanced Wound Care
Montgomery, Alabama, 36111
HealthEast Care System
Saint Paul, Minnesota, 55102
Jobst Vascular Institute
Toledo, Ohio, 43606
Canada2 sites
Lawson Health Research Institute
London, Ontario, N6C 0A7
Calea Ltd
Mississauga, Ontario, L4W 4Y3
About this study
Official title: A Randomized, Controlled, Clinical Study to Assess a New Adjustable Compression Device in Patients With Venous Leg Ulcers
The purpose of this study is to evaluate the product performance of a new adjustable compression system 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 adjustable compression system for the treatment of venous leg ulcers. The new compression system consists of a compression stocking and and adjustable compression sleeve. It will be used over primary dressings to provide compression that is beneficial to the healing of venous leg ulcers.
- Conditions
- Varicose Ulcer
- Being tested
- 3M™ Coban™ Custom Fit Compression System, Profore
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M™ Coban™ Custom Fit Compression SystemDevice
Also called Coban Fit Compression System
3M Coban™ Fit is a compression system that consists of two components: 1. A Compression Stocking and 2. Coban™ Fit Sleeve.
The stocking provides compression to the foot and improves wearing comfort in the calf area under the sleeve. The compression sleeve is intended to provide the therapeutic compression to the calf, with the initial fitting to be done by a health-care professional. The compression sleeve is customized according to the anatomy of the patient's leg; both components are designed to be used together.
ProforeDevice
PROFORE is a multi-layer compression bandaging system developed to apply sustained graduated compression for the management of venous leg ulcers and associated conditions. Multi-layer compression bandaging is the first choice in treatment for venous leg ulcers.
| Study group | Role | What they receive |
|---|---|---|
| 3M™ Coban™ Custom Fit Compression System | Experimental | 3M™ Coban™ Custom Fit Compression System will be custom-fitted at first subject visit and will thereafter be applied and removed daily by the study subject. It will be worn throughout the day by the study subject and removed before bedtime. It will provide therapeutic compression for edema control to help in the healing of venous leg ulcers. Receives: Device: 3M™ Coban™ Custom Fit Compression System |
| Profore | Active comparator | Profore multi-layer compression bandaging system will be applied at the first subject visit and will be worn by the study subject continuously for 7 days, at which time it will be replaced with a new system, or, in the case of a product or non-product reason, replaced before 7 days. It will provide therapeutic compression for edema control to help in the healing of venous leg ulcers Receives: Device: Profore |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the number of ulcers achieving complete closure (100% epithelialization) after 12 weeks
Measured: 12 weeks
Secondary outcomes (5)
Wound area reduction and relative wound area reduction at weeks 4, 8, and 12.
Measured: Up to 12 weeks
Relative wound area reduction >/= 40% at Week 4
Measured: 4 weeks
Time to complete closure
Measured: 1-12 weeks
Occurrence of treatment-related adverse events
Measured: 0-12 weeks
Occurrence of treatment-related drop-outs
Measured: 0-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3M
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick J Parks, MD, PhD, Study director, 3M Critical & Chronic Care Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561013
- Sponsor's protocol ID
- 05-013293
- Status last verified
- Nov 2015
- First submitted
- 23 Sep 2015
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Clinical Study to Assess a New Adjustable Compression Device in Patients With Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT02561013
- Acronym / sponsor ID
- 05-013293
- Conditions
- Varicose Ulcer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- 3MIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 25 Sep 2015 (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 adjustable compression system for the treatment of venous leg ulcers.
Detailed description
The purpose of this study is to evaluate the product performance of a new adjustable compression system for the treatment of venous leg ulcers. The new compression system consists of a compression stocking and and adjustable compression sleeve. It will be used over primary dressings to provide compression that is beneficial to the healing of venous leg ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3M™ Coban™ Custom Fit Compression System | Experimental | Device: 3M™ Coban™ Custom Fit Compression System3M™ Coban™ Custom Fit Compression System will be custom-fitted at first subject visit and will thereafter be applied and removed daily by the study subject. It will be worn throughout the day by the study subject and removed before bedtime. It will provide therapeutic compression for edema control to help in the healing of venous leg ulcers. |
| Profore | Active comparator | Device: ProforeProfore multi-layer compression bandaging system will be applied at the first subject visit and will be worn by the study subject continuously for 7 days, at which time it will be replaced with a new system, or, in the case of a product or non-product reason, replaced before 7 days. It will provide therapeutic compression for edema control to help in the healing of venous leg ulcers |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Is the subject 21 years or older?
- Does the subject have an active venous leg ulceration? If multiple ulcers are present, the investigator will need to select a single ulcer of the study leg that is > 2cm apart from any other ulcer?
- Does the subject have an ulcer size between 1cm2 and 12cm2?
- Does the subject have an ABPI between 0.8 and 1.3 that was taken within the past 28 days?
- Is the subject ambulatory?
Key exclusion criteria (13 listed)
- Does the subject have severe arterial occlusive disease?
- Does the subject have decompensated heart insufficiency NYHA Class IV, ACC.AHA Stage D?
- Does the subject have septic phlebitis?
- Does the subject have severe deep vein thrombosis (phlegmasia cerulea dolens) and other conditions contraindicated according to established guidelines and local procedures?
- Does the subject have known hypersensitivity to any of the component materials?
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 |
|---|---|---|
| 3M™ Coban™ Custom Fit Compression SystemAlso: Coban Fit Compression System3M Coban™ Fit is a compression system that consists of two components: 1. A Compression Stocking and 2. Coban™ Fit Sleeve. The stocking provides compression to the foot and improves wearing comfort in the calf area under the sleeve. The compression sleeve is intended to provide the therapeutic compression to the calf, with the initial fitting to be done by a health-care professional. The compression sleeve is customized according to the anatomy of the patient's leg; both components are designed to be used together. | Device | 3M™ Coban™ Custom Fit Compression System |
| ProforePROFORE is a multi-layer compression bandaging system developed to apply sustained graduated compression for the management of venous leg ulcers and associated conditions. Multi-layer compression bandaging is the first choice in treatment for venous leg ulcers. | Device | Profore |
Primary outcome
The primary efficacy endpoint is the number of ulcers achieving complete closure (100% epithelialization) after 12 weeks
Time frame: 12 weeks
5 secondary outcomes
Wound area reduction and relative wound area reduction at weeks 4, 8, and 12.
Time frame: Up to 12 weeks
Relative wound area reduction >/= 40% at Week 4
Time frame: 4 weeks
Time to complete closure
Time frame: 1-12 weeks
Occurrence of treatment-related adverse events
Time frame: 0-12 weeks
Occurrence of treatment-related drop-outs
Time frame: 0-12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
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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.
Patrick J Parks, MD, PhD study director
3M Critical & Chronic Care Division
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M™ Coban™ Custom Fit Compression System and Profore in people with Varicose Ulcer, run by 3M at 5 sites in 2 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 8 inclusion and 13 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: withdrawn, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, 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 was withdrawn before enrolling participants, so there are no results.
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?
The primary efficacy endpoint is the number of ulcers achieving complete closure (100% epithelialization) after 12 weeks (time frame: 12 weeks). 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 25 Nov 2015.