Back to resultsSafety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers
Primary Purpose
Leg Ulcers
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Biatain Ibu
Local best practice
Sponsored by
About this trial
This is an interventional treatment trial for Leg Ulcers
Eligibility 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
Sites / Locations
- Aarhus Universitetshospital
- Bispebjerg Hospital
- Odense Universitets Hospital
- Georg-August-Universität Göttingen
- Hospital de Fuenlabrada
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
1
2
No treatment
Arm Description
No treatment as wound was healed
Outcomes
Primary Outcome Measures
Adverse events
Secondary Outcome Measures
Clinical occurrences
Ulcer area reduction
Ulcer status
Skin condition at healed ulcer location
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00628004
Brief Title
Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers
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 Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open label
Allocation
Non-Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
No treatment as wound was healed
Intervention Type
Device
Intervention Name(s)
Biatain Ibu
Other Intervention Name(s)
Coloplast Biatain Ibu
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Local best practice
Intervention Description
N/A - since intervention is "local best practice"
Primary Outcome Measure Information:
Title
Adverse events
Time Frame
Week 1, 6, 20, 33, 46
Secondary Outcome Measure Information:
Title
Clinical occurrences
Time Frame
Week 1, 6, 20, 33, 46
Title
Ulcer area reduction
Time Frame
Week 1, 6, 20, 33, 46
Title
Ulcer status
Time Frame
Week 1, 6, 20, 33, 46
Title
Skin condition at healed ulcer location
Time Frame
Week 1, 6, 20, 33, 46
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karsten Fogh, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus Universitetshospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Odense Universitets Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Georg-August-Universität Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Hospital de Fuenlabrada
City
Fuenlabrada
ZIP/Postal Code
28942
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers
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