Back to resultsClinical Study to Assess Efficacy and Safety of a New Compression System in the Management of Venous Leg Ulcers (COMPULCE)
Primary Purpose
Venous Leg Ulcer
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Kit Biflex
Profore
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcer
Eligibility Criteria
Inclusion Criteria:
- Inpatients or outpatients.
- Agreeing to wear a multilayer compression system throughout the study period.
- Presenting with an active venous leg ulcer: Duration between 1-24 months (whether a new ulcer or a recurrent ulcer); Surface area between 2-50 cm2; Venous, superficial or post-thrombotic ulcer confirmed by Doppler ultrasonography (dated within six months).
- With ankle circumference between 18-25 cm to allow the laying of the compression system.
- Able to follow the study instructions.
- Having read the information sheet and dated and signed the informed consent form.
- Covered by a health insurance system.
Exclusion Criteria:
- Scheduled surgery for the ulcer during the 16 weeks following inclusion.
- Clinical superinfected ulcer not controlled oral antibiotics.
- Malignant ulcer.
- Ulcer surface totally covered with dry fibrinous tissue or covered with black necrotic plaque on over 10% of its surface.
- Deep Vein Thrombosis within the last 3 months.
- Corticosteroids treatment (equivalent to more than 10 mg per day of prednisolone) ongoing or planned during the study.
- Radiotherapy, chemotherapy or immunosuppressive therapy ongoing or planned during the study.
- Erysipelas and lymphangitis.
- Lower extremity arterial disease or microangiopathy (Ankle Brachial Pressure Index <0.8 or> 1.3).
- Uncontrolled non-insulin dependent diabetes (HbA1c> 8%).
- Insulin-dependent diabetes.
- Confined to bed.
- With any uncontrolled severe and progressive disease.
- With a known or suspected hypersensitivity to any of the components of the study devices.
- Who had participated in a previous clinical study within the past 3 months.
- Pregnant women.
Sites / Locations
- Thuasne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Kit Biflex
Profore
Arm Description
The Kit Biflex® will be applied according to manufacturer recommendations for 16 weeks or until full healing.
The compression system Profore will be applied according to manufacturer recommendations for 16 weeks or until full healing.
Outcomes
Primary Outcome Measures
Percentage of patients with complete wound closure (100% re-epithelialisation) over the treatment period
Nature and frequency of adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02782689
Brief Title
Clinical Study to Assess Efficacy and Safety of a New Compression System in the Management of Venous Leg Ulcers
Acronym
COMPULCE
Official Title
Evaluation of Efficacy and Safety of the 2-layer Compression System Kit Biflex® Versus the 4-layer Compression System PROFORE® in the Management of Venous Leg Ulcers (Stage C6).
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
difficulties in enrolling patients
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thuasne
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to demonstrate the non-inferiority of the 2-layer compression system Kit Biflex® with regard of the 4-layer compression system PROFORE® in the treatment of venous leg ulcers in terms of complete healing at 16 weeks.
Detailed Description
This trial is a multicentre, randomized, comparative, open label clinical study conducted in vascular medicine centres in France, with 2 parallel groups of 100 patients each. The study will be conducted in patients suffering from venous leg ulcer (stage C6 of the CEAP classification for chronic venous disorders).
The patients will be randomised at the inclusion: they will receive with either Kit Biflex® or the reference device (Profore®) for maximum 16 weeks (or until full healing).
Investigator assessments are planned every 4 weeks +/- 3 days, for 16 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kit Biflex
Arm Type
Experimental
Arm Description
The Kit Biflex® will be applied according to manufacturer recommendations for 16 weeks or until full healing.
Arm Title
Profore
Arm Type
Active Comparator
Arm Description
The compression system Profore will be applied according to manufacturer recommendations for 16 weeks or until full healing.
Intervention Type
Device
Intervention Name(s)
Kit Biflex
Intervention Description
Two-layer reusable compression system
Intervention Type
Device
Intervention Name(s)
Profore
Intervention Description
Four-layer compression system
Primary Outcome Measure Information:
Title
Percentage of patients with complete wound closure (100% re-epithelialisation) over the treatment period
Time Frame
16 weeks
Title
Nature and frequency of adverse events
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inpatients or outpatients.
Agreeing to wear a multilayer compression system throughout the study period.
Presenting with an active venous leg ulcer: Duration between 1-24 months (whether a new ulcer or a recurrent ulcer); Surface area between 2-50 cm2; Venous, superficial or post-thrombotic ulcer confirmed by Doppler ultrasonography (dated within six months).
With ankle circumference between 18-25 cm to allow the laying of the compression system.
Able to follow the study instructions.
Having read the information sheet and dated and signed the informed consent form.
Covered by a health insurance system.
Exclusion Criteria:
Scheduled surgery for the ulcer during the 16 weeks following inclusion.
Clinical superinfected ulcer not controlled oral antibiotics.
Malignant ulcer.
Ulcer surface totally covered with dry fibrinous tissue or covered with black necrotic plaque on over 10% of its surface.
Deep Vein Thrombosis within the last 3 months.
Corticosteroids treatment (equivalent to more than 10 mg per day of prednisolone) ongoing or planned during the study.
Radiotherapy, chemotherapy or immunosuppressive therapy ongoing or planned during the study.
Erysipelas and lymphangitis.
Lower extremity arterial disease or microangiopathy (Ankle Brachial Pressure Index <0.8 or> 1.3).
Uncontrolled non-insulin dependent diabetes (HbA1c> 8%).
Insulin-dependent diabetes.
Confined to bed.
With any uncontrolled severe and progressive disease.
With a known or suspected hypersensitivity to any of the components of the study devices.
Who had participated in a previous clinical study within the past 3 months.
Pregnant women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc GILLET, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thuasne
City
Levallois Perret
ZIP/Postal Code
92307
Country
France
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Assess Efficacy and Safety of a New Compression System in the Management of Venous Leg Ulcers
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