Back to resultsA Clinical Study to Assess a Compression Device in Patients With Venous Leg Ulcers
Primary Purpose
Varicose Ulcer
Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
3M™ Coban™ Custom Fit Compression System
Profore
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Ulcer
Eligibility Criteria
Inclusion Criteria:
- 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?
Exclusion Criteria:
- 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)?
- 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?
Sites / Locations
- Institute for Advanced Wound Care
- HealthEast Care System
- Jobst Vascular Institute
- Lawson Health Research Institute
- Calea Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3M™ Coban™ Custom Fit Compression System
Profore
Arm Description
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.
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
Outcomes
Primary Outcome Measures
The primary efficacy endpoint is the number of ulcers achieving complete closure (100% epithelialization) after 12 weeks
Secondary Outcome Measures
Wound area reduction and relative wound area reduction at weeks 4, 8, and 12.
Relative wound area reduction >/= 40% at Week 4
Time to complete closure
Occurrence of treatment-related adverse events
Occurrence of treatment-related drop-outs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02561013
Brief Title
A Clinical Study to Assess a Compression Device in Patients With Venous Leg Ulcers
Official Title
A Randomized, Controlled, Clinical Study to Assess a New Adjustable Compression Device in Patients With Venous Leg Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Business reasons
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3M™ Coban™ Custom Fit Compression System
Arm Type
Experimental
Arm Description
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.
Arm Title
Profore
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
3M™ Coban™ Custom Fit Compression System
Other Intervention Name(s)
Coban Fit Compression System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Profore
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary efficacy endpoint is the number of ulcers achieving complete closure (100% epithelialization) after 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Wound area reduction and relative wound area reduction at weeks 4, 8, and 12.
Time Frame
Up to 12 weeks
Title
Relative wound area reduction >/= 40% at Week 4
Time Frame
4 weeks
Title
Time to complete closure
Time Frame
1-12 weeks
Title
Occurrence of treatment-related adverse events
Time Frame
0-12 weeks
Title
Occurrence of treatment-related drop-outs
Time Frame
0-12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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?
Exclusion Criteria:
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)?
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?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J Parks, MD, PhD
Organizational Affiliation
3M Critical & Chronic Care Division
Official's Role
Study Director
Facility Information:
Facility Name
Institute for Advanced Wound Care
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111
Country
United States
Facility Name
HealthEast Care System
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Jobst Vascular Institute
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 0A7
Country
Canada
Facility Name
Calea Ltd
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 4Y3
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study to Assess a Compression Device in Patients With Venous Leg Ulcers
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