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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 16, 2018
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Leg Ulcers
Interventions: Device: Biatain Ag
Device: Biatain

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients could be in-patients, out-patients attending hospital clinics specialising in phlebo-angiology, dermatology or vascular surgery, or patients being treated in a non-hospital setting

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Biatain Ag Wound Dressing Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver
Biatain Wound Dressing Biatain dressing is a foam wound dressing

Participant Flow:   Overall Study
    Biatain Ag Wound Dressing   Biatain Wound Dressing
STARTED   88   94 
COMPLETED   77   75 
NOT COMPLETED   11   19 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biatain Ag Wound Dressing Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver
Biatain Wound Dressing Biatain dressing is a foam wound dressing
Total Total of all reporting groups

Baseline Measures
   Biatain Ag Wound Dressing   Biatain Wound Dressing   Total 
Overall Participants Analyzed 
[Units: Participants]
 88   94   182 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      18  20.5%      25  26.6%      43  23.6% 
>=65 years      70  79.5%      69  73.4%      139  76.4% 
Age 
[Units: Years]
Mean (Standard Deviation)
 75.1  (11.8)   72.1  (12.4)   73.5  (12.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      54  61.4%      44  46.8%      98  53.8% 
Male      34  38.6%      50  53.2%      84  46.2% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
France   38   38   76 
Germany   25   27   52 
Belgium   3   1   4 
Denmark   19   24   43 
United Kingdom   3   4   7 


  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Birte Petersen Jacobsen
Organization: Coloplast
phone: 004549110000 ext 1395
e-mail: DKBIR@coloplast.com



Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00807664     History of Changes
Other Study ID Numbers: FR008WS
First Submitted: December 11, 2008
First Posted: December 12, 2008
Results First Submitted: August 29, 2017
Results First Posted: December 11, 2017
Last Update Posted: January 16, 2018