Leg Ulcers
Conditions
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
Interventions
DEVICEBiatain Ag
Biatain Ag non adhesive ( ColoplastA/S), a polyurethane permeable backing film with an added silver complex, size 15X15. The product is CE marked
DEVICEBiatain
A standard polyurethane foam dressing Biatain non adhesive permeable backing film, size15X15 cm. the product is CE marked
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Total Number of Adverse Events | Day 0 to Day 70 | — |
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Biatain Ag Wound Dressing Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver | 88 |
| Biatain Wound Dressing Biatain dressing is a foam wound dressing | 94 |
| Total | 182 |
Baseline characteristics
| Characteristic | Biatain Ag Wound Dressing | Biatain Wound Dressing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 70 Participants | 69 Participants | 139 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 25 Participants | 43 Participants |
| Age, Continuous | 75.1 years STANDARD_DEVIATION 11.8 | 72.1 years STANDARD_DEVIATION 12.4 | 73.5 years STANDARD_DEVIATION 12.2 |
| Region of Enrollment Belgium | 3 Participants | 1 Participants | 4 Participants |
| Region of Enrollment Denmark | 19 Participants | 24 Participants | 43 Participants |
| Region of Enrollment France | 38 Participants | 38 Participants | 76 Participants |
| Region of Enrollment Germany | 25 Participants | 27 Participants | 52 Participants |
| Region of Enrollment United Kingdom | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Female | 54 Participants | 44 Participants | 98 Participants |
| Sex: Female, Male Male | 34 Participants | 50 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 88 | 2 / 94 |
| serious Total, serious adverse events | 5 / 88 | 7 / 94 |
Outcome results
Primary
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.
Time frame: Day 0 to Day 42
Population: A total of 182 subjects were randomised in the study (safety analysis set), however one patient was in systemic antibiotic treatment and was erroneously enrolled, hence the ITT analysis set comprised 181 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biatain Ag Wound Dressing | Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline | -41.5 Percentage change | Standard Deviation 38.8 |
| Biatain Wound Dressing | Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline | -35.0 Percentage change | Standard Deviation 44.9 |
Secondary
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.
Time frame: Day 0 to Day 70
Population: ITT (ANCOVA) - LOCF was applied for subjects not having a value at visit 3 but a value at visit 2 for the ulcer area
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Biatain Ag Wound Dressing | Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline | -59.7 Percentage change |
| Biatain Wound Dressing | Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline | -46.1 Percentage change |
Secondary
Total Number of Adverse Events
Time frame: Day 0 to Day 70
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biatain Ag Wound Dressing | Total Number of Adverse Events | moderate, possibly related | 2 Adverse Event |
| Biatain Ag Wound Dressing | Total Number of Adverse Events | severe, possibly related | 2 Adverse Event |
| Biatain Ag Wound Dressing | Total Number of Adverse Events | Moderate, not related | 11 Adverse Event |
| Biatain Ag Wound Dressing | Total Number of Adverse Events | severe, related | 0 Adverse Event |
| Biatain Ag Wound Dressing | Total Number of Adverse Events | moderate, related | 1 Adverse Event |
| Biatain Ag Wound Dressing | Total Number of Adverse Events | not specified, not related | 0 Adverse Event |
| Biatain Ag Wound Dressing | Total Number of Adverse Events | mild, possibly related | 1 Adverse Event |
| Biatain Ag Wound Dressing | Total Number of Adverse Events | Mild, not related | 3 Adverse Event |
| Biatain Ag Wound Dressing | Total Number of Adverse Events | severe, not related | 2 Adverse Event |
| Biatain Wound Dressing | Total Number of Adverse Events | Mild, not related | 2 Adverse Event |
| Biatain Wound Dressing | Total Number of Adverse Events | Moderate, not related | 11 Adverse Event |
| Biatain Wound Dressing | Total Number of Adverse Events | moderate, possibly related | 2 Adverse Event |
| Biatain Wound Dressing | Total Number of Adverse Events | moderate, related | 0 Adverse Event |
| Biatain Wound Dressing | Total Number of Adverse Events | severe, not related | 1 Adverse Event |
| Biatain Wound Dressing | Total Number of Adverse Events | severe, possibly related | 0 Adverse Event |
| Biatain Wound Dressing | Total Number of Adverse Events | severe, related | 2 Adverse Event |
| Biatain Wound Dressing | Total Number of Adverse Events | not specified, not related | 1 Adverse Event |
| Biatain Wound Dressing | Total Number of Adverse Events | mild, possibly related | 0 Adverse Event |