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Biatain Ag vs Biatain in the Treament of Leg Ulcers

Primary Purpose

Leg Ulcers

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Biatain Ag
Biatain
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Patients over 18 who have given written informed consent

    • Patients with a venous or predominantly venous leg ulcer (ankle-brachial index > 0.8) that is between 2 cm and 13 cm in all directions
    • Patients with a moderately or severely exudating leg ulcer in the phase of debridement or formation of granulation tissue
    • Patients with a leg ulcer that is not healing properly despite suitable and well-conducted local treatment in the four weeks prior to inclusion
    • Patients with a leg ulcer that has been treated with appropriate compression in the four weeks prior to inclusion
    • Patients who are available for monitoring for at least 10 weeks

Exclusion Criteria:

  • • Patients whose leg ulcers are clinically infected (including erysipelas and cellulitis of the skin around the ulcer) requiring systemic antibiotic treatment

    • Patients who have undergone surgery on the saphenous trunk within the two months prior to inclusion
    • Patients whose leg ulcer being considered for the study has been treated with local antibiotics or antiseptics incl. dressings containing antibiotics or antiseptics in the four weeks prior to inclusion
    • Patients who have been taking systemic antibiotics in the two weeks prior to inclusion
    • Patients who have been taking systemic corticoids or cytostatics within the three months prior to inclusion
    • Patients with unbalanced diabetes at the discretion of the investigator
    • Patients with a known allergy to one of the components in Biatain Argent® or Biatain
    • Patients who are already taking part in another clinical study
    • Patients who are pregnant or breastfeeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Biatain Ag dressing

    Biatain dressing

    Outcomes

    Primary Outcome Measures

    Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline
    The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation: Area= Lenght *Width * pi [3.142] / 4 All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used.

    Secondary Outcome Measures

    Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline
    The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation: Area= Lenght *Width * pi [3.142] / 4 All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used.
    Total Number of Adverse Events

    Full Information

    First Posted
    December 11, 2008
    Last Updated
    January 11, 2018
    Sponsor
    Coloplast A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00807664
    Brief Title
    Biatain Ag vs Biatain in the Treament of Leg Ulcers
    Official Title
    Clinical Assessment of Biatain Ag Dressings Compared to Biatain Dressings in the Treatment of Leg Ulcers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2008 (undefined)
    Primary Completion Date
    April 2010 (Actual)
    Study Completion Date
    April 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Coloplast A/S

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    the objective of this investigation is to demonstrate the effect of the foam dressing Biatain Ag, compared to Biatain foam dressing( a product which is similar but does not contain a silver complex, in the healing of leg ulcers that had failed to heal despite appropriate therapy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leg Ulcers

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    182 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Biatain Ag dressing
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Biatain dressing
    Intervention Type
    Device
    Intervention Name(s)
    Biatain Ag
    Intervention Description
    Biatain Ag non adhesive ( ColoplastA/S), a polyurethane permeable backing film with an added silver complex, size 15X15. The product is CE marked
    Intervention Type
    Device
    Intervention Name(s)
    Biatain
    Intervention Description
    A standard polyurethane foam dressing Biatain non adhesive permeable backing film, size15X15 cm. the product is CE marked
    Primary Outcome Measure Information:
    Title
    Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline
    Description
    The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation: Area= Lenght *Width * pi [3.142] / 4 All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used.
    Time Frame
    Day 0 to Day 42
    Secondary Outcome Measure Information:
    Title
    Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline
    Description
    The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation: Area= Lenght *Width * pi [3.142] / 4 All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used.
    Time Frame
    Day 0 to Day 70
    Title
    Total Number of Adverse Events
    Time Frame
    Day 0 to Day 70

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • Patients over 18 who have given written informed consent Patients with a venous or predominantly venous leg ulcer (ankle-brachial index > 0.8) that is between 2 cm and 13 cm in all directions Patients with a moderately or severely exudating leg ulcer in the phase of debridement or formation of granulation tissue Patients with a leg ulcer that is not healing properly despite suitable and well-conducted local treatment in the four weeks prior to inclusion Patients with a leg ulcer that has been treated with appropriate compression in the four weeks prior to inclusion Patients who are available for monitoring for at least 10 weeks Exclusion Criteria: • Patients whose leg ulcers are clinically infected (including erysipelas and cellulitis of the skin around the ulcer) requiring systemic antibiotic treatment Patients who have undergone surgery on the saphenous trunk within the two months prior to inclusion Patients whose leg ulcer being considered for the study has been treated with local antibiotics or antiseptics incl. dressings containing antibiotics or antiseptics in the four weeks prior to inclusion Patients who have been taking systemic antibiotics in the two weeks prior to inclusion Patients who have been taking systemic corticoids or cytostatics within the three months prior to inclusion Patients with unbalanced diabetes at the discretion of the investigator Patients with a known allergy to one of the components in Biatain Argent® or Biatain Patients who are already taking part in another clinical study Patients who are pregnant or breastfeeding

    12. IPD Sharing Statement

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    Biatain Ag vs Biatain in the Treament of Leg Ulcers

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