Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers

April 25, 2017 updated by: Coloplast A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • 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
  • Germany
      • Göttingen, Germany, 37075
        • Georg-August-Universität Göttingen
  • Spain
      • Fuenlabrada, Spain, 28942
        • Hospital De Fuenlabrada

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Week 1, 6, 20, 33, 46
Week 1, 6, 20, 33, 46

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical occurrences
Time Frame: Week 1, 6, 20, 33, 46
Week 1, 6, 20, 33, 46
Ulcer area reduction
Time Frame: Week 1, 6, 20, 33, 46
Week 1, 6, 20, 33, 46
Ulcer status
Time Frame: Week 1, 6, 20, 33, 46
Week 1, 6, 20, 33, 46
Skin condition at healed ulcer location
Time Frame: Week 1, 6, 20, 33, 46
Week 1, 6, 20, 33, 46

Collaborators and Investigators

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

Sponsor

Coloplast A/S

Investigators

  • 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

May 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

March 3, 2008

First Posted (Estimate)

March 4, 2008

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK144WS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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