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Biatain Ag vs Biatain in the Treament of Leg Ulcers

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ClinicalTrials.gov Identifier: NCT00807664
Recruitment Status : Completed
First Posted : December 12, 2008
Results First Posted : December 11, 2017
Last Update Posted : January 15, 2018
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Leg Ulcers Device: Biatain Ag Device: Biatain

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Assessment of Biatain Ag Dressings Compared to Biatain Dressings in the Treatment of Leg Ulcers
Study Start Date : December 2008
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Biatain Ag dressing
Device: Biatain Ag
Biatain Ag non adhesive ( ColoplastA/S), a polyurethane permeable backing film with an added silver complex, size 15X15. The product is CE marked
Active Comparator: 2
Biatain dressing
Device: Biatain
A standard polyurethane foam dressing Biatain non adhesive permeable backing film, size15X15 cm. the product is CE marked


Outcome Measures

Primary Outcome Measures :
  1. Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline [ Time Frame: Day 0 to Day 42 ]

    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 :
  1. Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline [ Time Frame: Day 0 to Day 70 ]

    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.


  2. Total Number of Adverse Events [ Time Frame: Day 0 to Day 70 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
More Information

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00807664     History of Changes
Other Study ID Numbers: FR008WS
First Posted: December 12, 2008    Key Record Dates
Results First Posted: December 11, 2017
Last Update Posted: January 15, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Ulcer
Leg Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases