Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-04-30

Brief Summary

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The objective of this investigation is to demonstrate the effectiveness and safety of Biatain Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing.

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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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Biatain Ibu

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.

Biatain

Group Type ACTIVE_COMPARATOR

Biatain

Intervention Type DEVICE

A standard polyurethane foam dressing Biatain non-adhesive (Coloplast A/S) with an elastic semi-permeable backing film, size 15x15 cm. The product is CE marked.

Interventions

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Biatain

A standard polyurethane foam dressing Biatain non-adhesive (Coloplast A/S) with an elastic semi-permeable backing film, size 15x15 cm. The product is CE marked.

Intervention Type DEVICE

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

Other Intervention Names

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Coloplast Biatain Coloplast Biatain-Ibu

Eligibility Criteria

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Inclusion Criteria

* \>= 18 years of age
* Chronic venous leg ulcer on the lower leg
* Ulcer duration \>= 8 weeks
* Pain intensity in study ulcer at least 4 on an 11-point numerical box scale (NBS): 0= no pain, 10= worst possible pain
* Exudate level moderate to high
* Ulcer size min 1.6 cm and max 11 cm in any direction
* Ankle/brachial index \>= 0.8
* Treated with moist wound healing during the past 2 weeks prior to inclusion
* Adequate compression therapy during the past 2 weeks prior to inclusion
* The patient is cognitive capable of evaluating his/her pain relief and pain intensity
* The patient is able to understand the treatment and is willing to comply with the treatment regimen.
* The patient is able to complete the patient diary
* The patient is willing and able to give written informed consent

Exclusion Criteria

* Painful ulcers that have been treatment resistant to analgesics for the past 6 months or more
* Pregnant or lactating women
* Known and verified hypersensitivity to any content of the products used in this investigation
* Local infection (bacterial imbalanced wound) in the study ulcer
* Clinical infection in the study ulcer
* Diseases: Vasculitis, erysipelas and cellulitis of the peri-ulcer skin
* The investigator considers the patient not eligible
* Diseases and conditions where ibuprofen or other analgesics are contraindicated (including known hypersensitivity to Aspirin (acetylsalicylic acid) or other analgesics, especially associated with a history of asthma, rhinitis or urticaria)
* Diabetes
* Use of per need medication for the past 3 days
* Concomitant treatment with systemic antibiotics other than nitrofurantoin
* Concomitant treatment with systemic corticosteroids (more than 10 mg/day prednisolon or equivalent) or other immunosuppressants within 1 month prior to inclusion
* Concomitant treatment with cancer chemotherapeutics
* Concomitant participation in other studies
* Previous participation in this study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No