CompletedNCT00807664Updated Jan 16, 2018Results posted

Biatain Ag vs Biatain in the Treament of Leg Ulcers

An interventional study of Biatain Ag and Biatain in Leg Ulcers, sponsored by Coloplast A/S. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-16.

Sponsored by Coloplast A/S · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 182
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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

Conditions studied

Leg Ulcers

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Leg Ulcer 302

In context

Leg Ulcer

302 studies on the registry are indexed under Leg Ulcer; 43 are open to participants now.

This study's enrollment of 182 is above the median of 60 across 245 interventional studies indexed under Leg Ulcer.

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Lead sponsor

Coloplast A/S is the lead sponsor of 150 studies on the registry; 8 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 182 participants (actual)

Study arms

Experimental
1
Biatain Ag dressing
Device: Biatain Ag
Active comparator
2
Biatain dressing
Device: Biatain

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

What researchers measure

Primary outcomes

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

Secondary outcomes

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
Total Number of Adverse Events
Time frame: Day 0 to Day 70

Results

Posted Dec 11, 2017

Participant flow

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

Participant flow — Overall Study
Milestone	Biatain Ag Wound Dressing	Biatain Wound Dressing
Started	88	94
Completed	77	75
Not completed	11	19

Outcome measures

PrimaryPercentage 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
Reported as:: Mean · Percentage change

Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline
Percentage change	Biatain Ag Wound Dressing	Biatain Wound Dressing
Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline	-41.5 ± 38.8	-35.0 ± 44.9

SecondaryPercentage 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
Reported as:: Mean · Percentage change

Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline
Percentage change	Biatain Ag Wound Dressing	Biatain Dressing
Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline	-59.7 (-78.8 to -40.6)	-46.1 (-65.4 to -26.8)

SecondaryTotal Number of Adverse Events

Time frame:: Day 0 to Day 70
Reported as:: Number · Adverse Event

Total Number of Adverse Events
Adverse Event	Biatain Ag Wound Dressing	Biatain Dressing
Mild, not related	3	2
mild, possibly related	1	0
Moderate, not related	11	11
moderate, possibly related	2	2
moderate, related	1	0
severe, not related	2	1
severe, possibly related	2	0
severe, related	0	2
not specified, not related	0	1

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Biatain Ag Wound Dressing	—	5/88 (5.7%)	4/88 (4.5%)
Biatain Wound Dressing	—	7/94 (7.4%)	2/94 (2.1%)

Most frequent serious events

Showing 10 of 12

Most frequent serious events
Event	Biatain Ag Wound Dressing	Biatain Wound Dressing
Recurrance opposite leg mlum perforans pedis infectionInfections and infestations	1/88	0/94
pneumoccal pneumonia hypoxemianteInfections and infestations	1/88	0/94
Arteriopathie left lower limbVascular disorders	1/88	0/94
Alteration of general stateSocial circumstances	1/88	0/94
Attack of anginaCardiac disorders	1/88	0/94
FallSocial circumstances	0/88	1/94
pulmonary embolismRespiratory, thoracic and mediastinal disorders	0/88	1/94
cardiac decompressionCardiac disorders	0/88	1/94
acute pulmonary edemaRespiratory, thoracic and mediastinal disorders	0/88	1/94
important pain on right legMusculoskeletal and connective tissue disorders	0/88	1/94

Most frequent other events

Most frequent other events
Event	Biatain Ag Wound Dressing	Biatain Wound Dressing
Maceration - eczema - redness - pain of wound and peri-wound skinSkin and subcutaneous tissue disorders	4/88	2/94

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Biatain Ag Wound Dressing	Biatain Wound Dressing	Total
<=18 years	0	0	0
Between 18 and 65 years	18	25	43
>=65 years	70	69	139

Age, Continuous
Age, Continuous(years)	Biatain Ag Wound Dressing	Biatain Wound Dressing	Total
Mean	75.1 ± 11.8	72.1 ± 12.4	73.5 ± 12.2

Sex: Female, Male
Sex: Female, Male(Participants)	Biatain Ag Wound Dressing	Biatain Wound Dressing	Total
Female	54	44	98
Male	34	50	84

Region of Enrollment
Region of Enrollment(Participants)	Biatain Ag Wound Dressing	Biatain Wound Dressing	Total
France	38	38	76
Germany	25	27	52
Belgium	3	1	4
Denmark	19	24	43
United Kingdom	3	4	7

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00807664
Lead sponsor: Coloplast A/S
Responsible party: Sponsor
First posted: Dec 12, 2008
Start date: Dec 2008
Primary completion: Apr 2010
Completion: Apr 2010
Results posted: Dec 11, 2017
Last update: Jan 16, 2018

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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