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Clinical Trials/NCT00628004
NCT00628004
Completed
Not Applicable

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

Coloplast A/S5 sites in 3 countries93 target enrollmentMay 2008
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ConditionsLeg Ulcers

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leg Ulcers
Sponsor
Coloplast A/S
Enrollment
93
Locations
5
Primary Endpoint
Adverse events
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2008
End Date
February 2010
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Adverse events

Time Frame: Week 1, 6, 20, 33, 46

Secondary Outcomes

  • 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)

Study Sites (5)

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