Safety Evaluation of Biatain Ibu in Painful Chronic Venou... | NCT00628004

Studies
Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers

NCT00628004

Sponsor

Coloplast A/S

Status

Completed

Last Update Posted

Apr 26, 2017Actual

Enrollment

93Actual

Phase

Not Applicable

Conditions

Leg Ulcers

Interventions

Biatain Ibu
Local best practice

Countries

Denmark
Germany
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DK144WS

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Jul 2009Actual

Completion Date

Feb 2010Actual

First Submitted Date

Feb 20, 2008

First Submission Date that Met QC Criteria

Mar 3, 2008

First Posted Date

Mar 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2017

Last Update Posted Date

Apr 26, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

93Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Device: Biatain Ibu
2	Active Comparator		Device: Local best practice
No treatment	No Intervention	No treatment as wound was healed

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biatain Ibu	Device	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Clinical occurrences		Week 1, 6, 20, 33, 46
Ulcer area reduction		Week 1, 6, 20, 33, 46
Ulcer status

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karsten Fogh, MD	Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus Universitetshospital		Aarhus		8000	Denmark
Bispebjerg Hospital

Condition Browse Module

MeSH Terms

ID	Term
D007871	Leg Ulcer

Ancestor Terms

ID	Term
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided