Leg UlcersNCT00627094

Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers

A study testing Biatain and Biatain Ibu in people with Leg Ulcers, run by Coloplast A/S at 13 sites in 4 countries.

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 effectiveness and safety of Biatain Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing. 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 and Biatain Ibu
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 13 sitesin 4 countries
Study dates: Mar 2008to Apr 2009
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

>= 18 years of age
Chronic venous leg ulcer on the lower leg
Ulcer duration >= 8 weeks
Pain intensity in study ulcer at least 4 on an 11-point numerical box scale (NBS): 0= no pain, 10= worst possible pain
Exudate level moderate to high
Ulcer size min 1.6 cm and max 11 cm in any direction

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Ankle/brachial index >= 0.8
Treated with moist wound healing during the past 2 weeks prior to inclusion
Adequate compression therapy during the past 2 weeks prior to inclusion
The patient is cognitive capable of evaluating his/her pain relief and pain intensity
The patient is able to understand the treatment and is willing to comply with the treatment regimen.
The patient is able to complete the patient diary
The patient is willing and able to give written informed consent

Who cannot join

Painful ulcers that have been treatment resistant to analgesics for the past 6 months or more
Pregnant or lactating women
Known and verified hypersensitivity to any content of the products used in this investigation
Local infection (bacterial imbalanced wound) in the study ulcer
Clinical infection in the study ulcer
Diseases: Vasculitis, erysipelas and cellulitis of the peri-ulcer skin

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The investigator considers the patient not eligible
Diseases and conditions where ibuprofen or other analgesics are contraindicated (including known hypersensitivity to Aspirin (acetylsalicylic acid) or other analgesics, especially associated with a history of asthma, rhinitis or urticaria)
Diabetes
Use of per need medication for the past 3 days
Concomitant treatment with systemic antibiotics other than nitrofurantoin
Concomitant treatment with systemic corticosteroids (more than 10 mg/day prednisolon or equivalent) or other immunosuppressants within 1 month prior to inclusion
Concomitant treatment with cancer chemotherapeutics
Concomitant participation in other studies
Previous participation in this study

Trial locations and contacts

13 sites in 4 countries.

Country

City, postcode or hospital

13 sites in 4 countries

Germany6 sites

Department for Dermatology, University School of Medicine
Essen, 45122
Georg-August-Universität Göttingen
Göttingen, 37075
Klinik für Dermatologie und Venerologie
Hanover, 30449
Universitätsklinikum des Saarlandes
Homburg/Saar, 66421
Dr. Renzo Bause Praxis
Lüdenscheid, 58511
Fachartzpraxis für Dermatologie, Allergologie, Lasermedizin
Mahlow, 15831

Other trials in Germany

Denmark3 sites

Aarhus Universitetshospital
Aarhus, 8000
Bispebjerg Hospital
Copenhagen, 2400
Odense Universitets Hospital
Odense, 5000

Other trials in Denmark

France2 sites

CHU de Brest
Arras, 62000
CHU de Nancy - Hôpital Fournier
Nancy, 54035

Other trials in France

Spain2 sites

Hospital de Fuenlabrada
Fuenlabrada, 28942
C.S. SERGAS Rosalía de Castro - Enfermero
Vigo, Pontevedra, 36201

Other trials in Spain

About this study

Official title: A Randomised, Controlled and Double-blind Clinical Investigation on the Effectiveness and Safety of a Foam Dressing Biatain Ibu Non-adhesive vs. Biatain Non-adhesive, in Painful Chronic Venous Leg Ulcers

The objective of this investigation is to demonstrate the effectiveness and safety of Biatain Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing.

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

What participants receive

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

BiatainDevice
Also called Coloplast Biatain
A standard polyurethane foam dressing Biatain non-adhesive (Coloplast A/S) with an elastic semi-permeable backing film, size 15x15 cm. The product is CE marked.
Biatain IbuDevice
Also called Coloplast Biatain-Ibu
Biatain Ibu non-adhesive (Coloplast A/S), a polyurethane foam dressing with an elastic semi-permeable backing film with an added pain relieving medicinal substance ibuprofen (Albermarle Inc.), size 15x15 cm. The product is CE marked.

Study groups in NCT00627094
Study group	Role	What they receive
Biatain Ibu	Experimental	Biatain Ibu Receives: Device: Biatain Ibu
Biatain	Active comparator	Biatain Receives: Device: Biatain

What is being measured

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

Pain Relief
The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment.
Measured: Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)

Secondary outcomes (3)

Pain Intensity (PI) Change
Pain intensity (PI) assesment performed daily during the days 1-5. Pain intensity assesment performed on a 11 point numerical box scale: 0 was no pain and 10 was worst possible pain. A positive outcome measure value (PI (baseline) - PI (day 4 evening)) means that PI has decreased since baseline and thus reflects clinical improvement (patients suffer less from pain).
Measured: Change from baseline in Pain Intensity (PI) on day 4 evening
Change From Baseline in Ulcer Area
Relative change from baseline in ulcer area using last observation carried forward. A positive outcome value Means that wound size has decreased and thus reflects wound healing (clinical improvement)
Measured: Change from baseline to end of trial (day 43)
Adverse Events
Number of Adverse events reported which were evaluated to be related or possible related to the device
Measured: Continuously from start of treatment to end of trial (day 43)

Timeline

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

Mar 2008Apr 2009

First posted29 Feb 2008 (estimated)
Study startMar 2008
Primary completionApr 2009
Study completionApr 2009

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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00627094
Sponsor's protocol ID: DK143WS
Status last verified: Aug 2017
First submitted: 20 Feb 2008
Last updated: 15 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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?

See locations

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 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Controlled and Double-blind Clinical Investigation on the Effectiveness and Safety of a Foam Dressing Biatain Ibu Non-adhesive vs. Biatain Non-adhesive, in Painful Chronic Venous Leg Ulcers
ClinicalTrials.gov ID: NCT00627094
Acronym / sponsor ID: DK143WS
Conditions: Leg Ulcers
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 29 Feb 2008 (estimated)
Results: Posted 7 Feb 2017

Clinical summary

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

The objective of this investigation is to demonstrate the effectiveness and safety of Biatain Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Biatain Ibu	Experimental	Device: Biatain IbuBiatain Ibu
Biatain	Active comparator	Device: BiatainBiatain

Who may qualify

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

Key inclusion criteria (13 listed)

>= 18 years of age
Chronic venous leg ulcer on the lower leg
Ulcer duration >= 8 weeks
Pain intensity in study ulcer at least 4 on an 11-point numerical box scale (NBS): 0= no pain, 10= worst possible pain
Exudate level moderate to high

Key exclusion criteria (15 listed)

Painful ulcers that have been treatment resistant to analgesics for the past 6 months or more
Pregnant or lactating women
Known and verified hypersensitivity to any content of the products used in this investigation
Local infection (bacterial imbalanced wound) in the study ulcer
Clinical infection in the study ulcer

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
BiatainAlso: Coloplast BiatainA standard polyurethane foam dressing Biatain non-adhesive (Coloplast A/S) with an elastic semi-permeable backing film, size 15x15 cm. The product is CE marked.	Device	Biatain
Biatain IbuAlso: Coloplast Biatain-IbuBiatain Ibu non-adhesive (Coloplast A/S), a polyurethane foam dressing with an elastic semi-permeable backing film with an added pain relieving medicinal substance ibuprofen (Albermarle Inc.), size 15x15 cm. The product is CE marked.	Device	Biatain Ibu

Primary outcome

Pain Relief
Time frame: Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)
The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment.

3 secondary outcomes

Pain Intensity (PI) Change
Time frame: Change from baseline in Pain Intensity (PI) on day 4 evening
Change From Baseline in Ulcer Area
Time frame: Change from baseline to end of trial (day 43)
Adverse Events
Time frame: Continuously from start of treatment to end of trial (day 43)

Results and safety

Results posted to the registry on 7 Feb 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 Ibu	60	48
Biatain	60	45

Primary outcome: Pain Relief

Time frame: Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning). Number. Unit: percentage of scores within category

Measure	Biatain Ibu n = 59	Biatain n = 59
No Pain Relief	22	31
Slight Pain Relief	26	31
Moderate Pain Relief	30	26
A lot Pain Relief	19	11
Complete Pain Relief	3	1

Biatain Ibu vs Biatain: Odds Ratio (OR): 1.73 (95% CI 1.02 to 2.96), p = 0.0438, Chi-squared

Population analysed: ITT population

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Biatain Ibu	0 of 60 (0%)	4 of 60 (6.7%)	Not reported
Biatain	1 of 60 (1.7%)	6 of 60 (10%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

Karsten Fogh, MD principal investigator

Aarhus University Hospital

13 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Biatain and Biatain Ibu in people with Leg Ulcers, run by Coloplast A/S at 13 sites in 4 countries.

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 13 inclusion and 15 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 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany, Denmark, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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 7 Feb 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?

Pain Relief (time frame: Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)). 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 NCT00627094.

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 15 Sep 2017.