Leg UlcersNCT00807664

Biatain Ag vs Biatain in the Treament of Leg Ulcers

A study testing Biatain Ag and Biatain in people with Leg Ulcers, run by Coloplast A/S.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Leg Ulcers
What is being tested?: Biatain Ag and Biatain
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 182 participants
Where: No sites listed yet
Study dates: Dec 2008to Apr 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

• 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

Who cannot join

• 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

Show all 9Show fewer

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

About this study

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

Conditions: Leg Ulcers
Being tested: Biatain Ag, Biatain
Medical subject headings: Leg Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biatain AgDevice
Biatain Ag non adhesive ( ColoplastA/S), a polyurethane permeable backing film with an added silver complex, size 15X15. The product is CE marked
BiatainDevice
A standard polyurethane foam dressing Biatain non adhesive permeable backing film, size15X15 cm. the product is CE marked

Study groups in NCT00807664
Study group	Role	What they receive
1	Experimental	Biatain Ag dressing Receives: Device: Biatain Ag
2	Active comparator	Biatain dressing Receives: Device: Biatain

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 0 to Day 42

Secondary outcomes (2)

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.
Measured: Day 0 to Day 70
Total Number of Adverse Events
Measured: Day 0 to Day 70

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Apr 2010

First posted12 Dec 2008 (estimated)
Study startDec 2008
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Leg UlcersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 182 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00807664
Sponsor's protocol ID: FR008WS
Status last verified: Jan 2018
First submitted: 11 Dec 2008
Last updated: 16 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer

All Leg Ulcers trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Assessment of Biatain Ag Dressings Compared to Biatain Dressings in the Treatment of Leg Ulcers
ClinicalTrials.gov ID: NCT00807664
Acronym / sponsor ID: FR008WS
Conditions: Leg Ulcers
Study type: Interventional
Recruitment status: Completed
Enrolment: 182 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 12 Dec 2008 (estimated)
Results: Posted 11 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Device: Biatain AgBiatain Ag dressing
2	Active comparator	Device: BiatainBiatain dressing

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

• Patients over 18 who have given written informed consent

Key exclusion criteria (9 listed)

• Patients whose leg ulcers are clinically infected (including erysipelas and cellulitis of the skin around the ulcer) requiring systemic antibiotic treatment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Biatain AgBiatain Ag non adhesive ( ColoplastA/S), a polyurethane permeable backing film with an added silver complex, size 15X15. The product is CE marked	Device	1
BiatainA standard polyurethane foam dressing Biatain non adhesive permeable backing film, size15X15 cm. the product is CE marked	Device	2

Primary outcome

Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline
Time frame: 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.

2 secondary outcomes

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

Results and safety

Results posted to the registry on 11 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Biatain Ag Wound Dressing	88	77
Biatain Wound Dressing	94	75

Primary outcome: Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline

Time frame: Day 0 to Day 42. Mean (Standard Deviation). Unit: Percentage change

Measure	Biatain Ag Wound Dressing n = 87	Biatain Wound Dressing n = 94
Value	-41.5 (38.8)	-35.0 (44.9)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Biatain Ag Wound Dressing	5 of 88 (5.7%)	4 of 88 (4.5%)	Not reported
Biatain Wound Dressing	7 of 94 (7.4%)	2 of 94 (2.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Leg Ulcers

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Biatain Ag and Biatain in people with Leg Ulcers, run by Coloplast A/S.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline (time frame: Day 0 to Day 42). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00807664.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.