Biatain Ag vs Biatain in the Treament of Leg Ulcers

Not Applicable

Completed

• Conditions: Leg Ulcers
• Interventions: Device: Biatain; Device: Biatain Ag

• Registration Number: NCT00807664
• Lead Sponsor: Coloplast A/S

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 available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-11
• Study First Submitted QC: 2008-12-11
• Study First Posted: 2008-12-12
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2017-08-29
• Results First Submitted QC: 2017-11-02
• Results First Posted: 2017-12-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Biatain	Biatain dressing
1	Biatain Ag	Biatain Ag dressing

Primary Outcome Measures

Name	Time	Method
Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline	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

Name	Time	Method
Total Number of Adverse Events	Day 0 to Day 70
Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline	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.