Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers

Leg Ulcers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628004
• Other study ID #: DK144WS
• Secondary ID: DK144WS
• Status: Completed
• Phase: N/A
• First received: February 20, 2008
• Last updated: April 25, 2017
• Start date: May 2008
• Est. completion date: February 2010

Study information

• Verified date: April 2017
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: February 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Leg Ulcers
• Ulcer
• Varicose Ulcer

Intervention

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.
• Local best practice
N/A - since intervention is "local best practice"

Locations

Country	Name	City	State
Denmark	Aarhus Universitetshospital	Aarhus
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Odense Universitets Hospital	Odense
Germany	Georg-August-Universität Göttingen	Göttingen
Spain	Hospital de Fuenlabrada	Fuenlabrada

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

Denmark,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		Week 1, 6, 20, 33, 46
Secondary	Clinical occurrences		Week 1, 6, 20, 33, 46
Secondary	Ulcer area reduction		Week 1, 6, 20, 33, 46
Secondary	Ulcer status		Week 1, 6, 20, 33, 46
Secondary	Skin condition at healed ulcer location		Week 1, 6, 20, 33, 46