Biatain Ag vs Biatain in the Treament of Leg Ulcers

Study Overview
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Brief Summary
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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

Official Title
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Clinical Assessment of Biatain Ag Dressings Compared to Biatain Dressings in the Treatment of Leg Ulcers

Conditions
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Leg Ulcers

Intervention / Treatment
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* Device: Biatain Ag
* Device: Biatain


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Biatain Ag dressing | Device: Biatain Ag<br>* Biatain Ag non adhesive ( ColoplastA/S), a polyurethane permeable backing film with an added silver complex, size 15X15. The product is CE marked<br>|
| Active Comparator: 2<br>Biatain dressing | Device: Biatain<br>* A standard polyurethane foam dressing Biatain non adhesive permeable backing film, size15X15 cm. the product is CE marked<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline | 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. | Day 0 to Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline | 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. | Day 0 to Day 70 | 
| Total Number of Adverse Events |  | Day 0 to Day 70 |