Status:
COMPLETED
Biatain Ag vs Biatain in the Treament of Leg Ulcers
Lead Sponsor:
Coloplast A/S
Conditions:
Leg Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
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, i...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00807664
Start Date
December 1 2008
End Date
April 1 2010
Last Update
January 16 2018
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