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Biatain Ag vs Biatain in the Treament of Leg Ulcers

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: December 12, 2008
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Coloplast A/S
December 11, 2008
December 12, 2008
November 6, 2017
December 2008
April 2010   (Final data collection date for primary outcome measure)
relative variation in the area of the leg measured by planimetry at week 6 compared to the area at inclusion [ Time Frame: Day 0, 28, 42,70 ]
Same as current
Complete list of historical versions of study NCT00807664 on ClinicalTrials.gov Archive Site
  • relative reduction of the area of the leg ulcer at 10 weeks [ Time Frame: day 0, D28, D42, D70 ]
  • Adverse events [ Time Frame: continuously ]
Same as current
Not Provided
Not Provided
Biatain Ag vs Biatain in the Treament of Leg Ulcers
Clinical Assessment of Biatain Ag Dressings Compared to Biatain Dressings in the Treatment of Leg Ulcers
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
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Leg Ulcers
  • 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
  • Device: Biatain
    A standard polyurethane foam dressing Biatain non adhesive permeable backing film, size15X15 cm. the product is CE marked
  • Experimental: 1
    Biatain Ag dressing
    Intervention: Device: Biatain Ag
  • Active Comparator: 2
    Biatain dressing
    Intervention: Device: Biatain
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2010
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Ghislaine Martin, Clinical Trial Manager, Coloplast A/S
Coloplast A/S
Not Provided
Not Provided
Coloplast A/S
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP