Biatain Ag vs Biatain in the Treament of Leg Ulcers

This study has been completed.
Sponsor:
Information provided by:
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00807664
First received: December 11, 2008
Last updated: June 2, 2010
Last verified: June 2010

December 11, 2008
June 2, 2010
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: continuously ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.
 
Completed
183
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00807664
FR008WS
No
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