Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers
CompletedNot applicableNCT00628004
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Leg Ulcers
- Interventions
- Device: Biatain Ibu
- Device: Local best practice
- Sponsor
- Coloplast A/S
- Start date
- 2008-05
- Primary completion
- 2009-07
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark, Germany, Spain
- Total sites listed
- 5
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00628004