Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00628004
Recruitment Status : Completed
First Posted : March 4, 2008
Last Update Posted : April 26, 2017
Information provided by (Responsible Party):
Coloplast A/S

Brief 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.

Condition or disease Intervention/treatment
Leg Ulcers Device: Biatain Ibu Device: Local best practice

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
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
Study Start Date : May 2008
Primary Completion Date : July 2009
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 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 Name: Coloplast Biatain Ibu
Active Comparator: 2 Device: Local best practice
N/A - since intervention is "local best practice"
No Intervention: No treatment
No treatment as wound was healed

Primary Outcome Measures :
  1. Adverse events [ Time Frame: Week 1, 6, 20, 33, 46 ]

Secondary Outcome Measures :
  1. Clinical occurrences [ Time Frame: Week 1, 6, 20, 33, 46 ]
  2. Ulcer area reduction [ Time Frame: Week 1, 6, 20, 33, 46 ]
  3. Ulcer status [ Time Frame: Week 1, 6, 20, 33, 46 ]
  4. Skin condition at healed ulcer location [ Time Frame: Week 1, 6, 20, 33, 46 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant or lactating women
  • Concomitant participation in other studies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00628004

Aarhus Universitetshospital
Aarhus, Denmark, 8000
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Odense Universitets Hospital
Odense, Denmark, 5000
Georg-August-Universität Göttingen
Göttingen, Germany, 37075
Hospital de Fuenlabrada
Fuenlabrada, Spain, 28942
Sponsors and Collaborators
Coloplast A/S
Principal Investigator: Karsten Fogh, MD Aarhus University Hospital

Responsible Party: Coloplast A/S Identifier: NCT00628004     History of Changes
Other Study ID Numbers: DK144WS
First Posted: March 4, 2008    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases