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OpenTrials
Completed

NCT Number: NCT00628004

Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers

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.

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Key information

Conditions

Leg Ulcers Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus Universitetshospital, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Coloplast Biatain Ibu

Local best practice

Device

N/A - since intervention is "local best practice"

Primary outcomes

  1. Adverse events

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

Secondary outcomes

  1. Clinical occurrences

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

  2. Ulcer area reduction

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

  3. Ulcer status

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

  4. Skin condition at healed ulcer location

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

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Mar 4, 2008
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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