Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers

August 17, 2017 updated by: Coloplast A/S

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus Universitetshospital
      • Copenhagen, Denmark, 2400
        • Bispebjerg Hospital
      • Odense, Denmark, 5000
        • Odense Universitets Hospital
  • France
      • Arras, France, 62000
        • CHU de Brest
      • Nancy Cedex, France, 54035
        • CHU de Nancy - Hôpital Fournier
  • Germany
      • Essen, Germany, 45122
        • Department for Dermatology, University School of Medicine
      • Göttingen, Germany, 37075
        • Georg-August-Universität Göttingen
      • Hannover, Germany, 30449
        • Klinik für Dermatologie und Venerologie
      • Homburg/Saar, Germany, 66421
        • Universitatsklinikum des Saarlandes
      • Luedenscheid, Germany, 58511
        • Dr. Renzo Bause Praxis
      • Mahlow, Germany, 15831
        • Fachartzpraxis für Dermatologie, Allergologie, Lasermedizin
  • Spain
      • Fuenlabrada, Spain, 28942
        • Hospital De Fuenlabrada
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36201
        • C.S. SERGAS Rosalía de Castro - Enfermero

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >= 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Biatain Ibu
Device: 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.
Other Names:
  • Coloplast Biatain-Ibu
Active Comparator: Biatain
Device: 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.
Other Names:
  • Coloplast Biatain

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Intensity (PI) Change
Time Frame: Change from baseline in Pain Intensity (PI) on day 4 evening
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).
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)
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)
Change from baseline to end of trial (day 43)
Adverse Events
Time Frame: Continuously from start of treatment to end of trial (day 43)
Number of Adverse events reported which were evaluated to be related or possible related to the device
Continuously from start of treatment to end of trial (day 43)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Coloplast A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karsten Fogh, MD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DK143WS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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