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Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00628004
First received: February 20, 2008
Last updated: April 25, 2017
Last verified: April 2017
  Purpose
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 Intervention
Leg Ulcers Device: Biatain Ibu Device: Local best practice

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 93
Study Start Date: May 2008
Study Completion Date: February 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628004

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

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00628004     History of Changes
Other Study ID Numbers: DK144WS
Study First Received: February 20, 2008
Last Updated: April 25, 2017

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

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

ClinicalTrials.gov processed this record on August 23, 2017