Leg UlcersNCT00628004
Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers
A study testing Biatain Ibu and Local best practice in people with Leg Ulcers, run by Coloplast A/S at 5 sites in 3 countries.
Trial summary
The objective of this open label extension study (extension to study DK143WS) is to evaluate the safety of Biatain Ibu during 6 -12 weeks of exposure and during a 40 - 46 weeks safety follow-up period. 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 Ibu and Local best practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 5 sitesin 3 countries
- Study dates
- May 2008to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- The patient has participated in study DK143WS
- The patient is able to understand the treatment and is willing to comply with the treat-ment regimen.
- The patient is willing and able to give written informed consent
Who cannot join
- Pregnant or lactating women
- Concomitant participation in other studies
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Denmark3 sites
Aarhus Universitetshospital
Aarhus, 8000
Bispebjerg Hospital
Copenhagen, 2400
Odense Universitets Hospital
Odense, 5000
About this study
Official title: An Open Label Extension Study (to Study DK143WS) Evaluating the Safety and Long-term Safety Follow-up of Biatain Ibu in Painful Chronic Venous Leg Ulcers
The objective of this open label extension study (extension to study DK143WS) is to evaluate the safety of Biatain Ibu during 6 -12 weeks of exposure and during a 40 - 46 weeks safety follow-up period.
- Conditions
- Leg Ulcers
- Being tested
- Biatain Ibu, Local best practice
- 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 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.
Local best practiceDevice
N/A - since intervention is "local best practice"
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Biatain Ibu |
| 2 | Active comparator | Not described Receives: Device: Local best practice |
| No treatment | No intervention | No treatment as wound was healed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: Week 1, 6, 20, 33, 46
Secondary outcomes (4)
Clinical occurrences
Measured: Week 1, 6, 20, 33, 46
Ulcer area reduction
Measured: Week 1, 6, 20, 33, 46
Ulcer status
Measured: Week 1, 6, 20, 33, 46
Skin condition at healed ulcer location
Measured: Week 1, 6, 20, 33, 46
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karsten Fogh, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628004
- Sponsor's protocol ID
- DK144WS
- Other IDs
- DK144WS
- Status last verified
- Apr 2017
- First submitted
- 20 Feb 2008
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Extension Study (to Study DK143WS) Evaluating the Safety and Long-term Safety Follow-up of Biatain Ibu in Painful Chronic Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT00628004
- Acronym / sponsor ID
- DK144WS
- Conditions
- Leg Ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 4 Mar 2008 (estimated)
- Results
- Not posted in the source record
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 open label extension study (extension to study DK143WS) is to evaluate the safety of Biatain Ibu during 6 -12 weeks of exposure and during a 40 - 46 weeks safety follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Biatain Ibu |
| 2 | Active comparator | Device: Local best practice |
| No treatment | No intervention | –No treatment as wound was healed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient has participated in study DK143WS
- The patient is able to understand the treatment and is willing to comply with the treat-ment regimen.
- The patient is willing and able to give written informed consent
Key exclusion criteria (2 listed)
- Pregnant or lactating women
- Concomitant participation in other studies
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 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 | 1 |
| Local best practiceN/A - since intervention is "local best practice" | Device | 2 |
Primary outcome
Adverse events
Time frame: Week 1, 6, 20, 33, 46
4 secondary outcomes
Clinical occurrences
Time frame: Week 1, 6, 20, 33, 46
Ulcer area reduction
Time frame: Week 1, 6, 20, 33, 46
Ulcer status
Time frame: Week 1, 6, 20, 33, 46
Skin condition at healed ulcer location
Time frame: Week 1, 6, 20, 33, 46
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
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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
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biatain Ibu and Local best practice in people with Leg Ulcers, run by Coloplast A/S at 5 sites in 3 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 3 inclusion and 2 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 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Germany, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse events (time frame: Week 1, 6, 20, 33, 46). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2017.