Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Leg Ulcers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label

Study Groups

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1

Group Type EXPERIMENTAL

Biatain Ibu

Intervention Type 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.

2

Group Type ACTIVE_COMPARATOR

Local best practice

Intervention Type DEVICE

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

No treatment

No treatment as wound was healed

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Local best practice

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

Intervention Type DEVICE

Other Intervention Names

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Coloplast Biatain Ibu

Eligibility Criteria

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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