Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers

Study Overview
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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.

Official Title
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A Randomised, Controlled and Double-blind Clinical Investigation on the Effectiveness and Safety of a Foam Dressing Biatain Ibu Non-adhesive vs. Biatain Non-adhesive, in Painful Chronic Venous Leg Ulcers

Conditions
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Leg Ulcers

Intervention / Treatment
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* Device: Biatain
* Device: Biatain Ibu


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biatain Ibu<br>Biatain Ibu | Device: Biatain Ibu<br>* 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.<br>* Other names: Coloplast Biatain-Ibu;|
| Active Comparator: Biatain<br>Biatain | Device: Biatain<br>* 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.<br>* Other names: Coloplast Biatain;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief | The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment. | Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity (PI) Change | Pain intensity (PI) assesment performed daily during the days 1-5. Pain intensity assesment performed on a 11 point numerical box scale: 0 was no pain and 10 was worst possible pain. A positive outcome measure value (PI (baseline) - PI (day 4 evening)) means that PI has decreased since baseline and thus reflects clinical improvement (patients suffer less from pain). | Change from baseline in Pain Intensity (PI) on day 4 evening | 
| Change From Baseline in Ulcer Area | Relative change from baseline in ulcer area using last observation carried forward. A positive outcome value Means that wound size has decreased and thus reflects wound healing (clinical improvement) | Change from baseline to end of trial (day 43) | 
| Adverse Events | Number of Adverse events reported which were evaluated to be related or possible related to the device | Continuously from start of treatment to end of trial (day 43) |