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

History of Changes

Tracking Information
First Received Date ^ICMJE	December 11, 2008
Last Updated Date	June 2, 2010
Start Date ^ICMJE	December 2008
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 11, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00807664 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 11, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Biatain Ag vs Biatain in the Treament of Leg Ulcers
Official Title ^ICMJE	Clinical Assessment of Biatain Ag Dressings Compared to Biatain Dressings in the Treatment of Leg Ulcers
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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Leg Ulcers
Intervention ^ICMJE	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
Study Arm (s)	Experimental: 1 Biatain Ag dressing Intervention: Device: Biatain Ag Active Comparator: 2 Biatain dressing Intervention: Device: Biatain
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	183
Completion Date	April 2010
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00807664
Other Study ID Numbers ^ICMJE	FR008WS
Has Data Monitoring Committee	No
Responsible Party	Ghislaine Martin, Clinical Trial Manager, Coloplast A/S
Study Sponsor ^ICMJE	Coloplast A/S
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Coloplast A/S
Verification Date	June 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top