Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers

Not Applicable

Completed

• Conditions: Leg Ulcers
• Interventions: Device: Biatain Ibu; Device: Local best practice

• Registration Number: NCT00628004
• Lead Sponsor: Coloplast A/S

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 available

Study Timeline

• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-03-03
• Study First Posted: 2008-03-04
• Study Start: 2008-05
• Primary Completion: 2009-07
• Study Completion: 2010-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Biatain Ibu	-
2	Local best practice	-

Primary Outcome Measures

Name	Time	Method
Adverse events	Week 1, 6, 20, 33, 46

Secondary Outcome Measures

Name	Time	Method
Clinical occurrences	Week 1, 6, 20, 33, 46
Ulcer area reduction	Week 1, 6, 20, 33, 46
Ulcer status	Week 1, 6, 20, 33, 46
Skin condition at healed ulcer location	Week 1, 6, 20, 33, 46

Trial Locations

Locations (5)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Odense Universitets Hospital; 🇩🇰 Odense, Denmark

Georg-August-Universität Göttingen; 🇩🇪 Göttingen, Germany

Hospital de Fuenlabrada; 🇪🇸 Fuenlabrada, Spain

Aarhus Universitetshospital; 🇩🇰 Aarhus, Denmark