Clinical trial NCT00627094: Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Ulcers
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain Relief
timeFrame: Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)
Secondary outcomes:
measure: Pain Intensity (PI) Change
timeFrame: Change from baseline in Pain Intensity (PI) on day 4 evening
measure: Change From Baseline in Ulcer Area
timeFrame: Change from baseline to end of trial (day 43)
measure: Adverse Events
timeFrame: Continuously from start of treatment to end of trial (day 43)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Odense
country: Denmark
facility: Odense Universitets Hospital
city: Arras
country: France
facility: CHU de Brest
city: Nancy Cedex
country: France
facility: CHU de Nancy - Hôpital Fournier
city: Essen
country: Germany
facility: Department for Dermatology, University School of Medicine
city: Göttingen
country: Germany
facility: Georg-August-Universität Göttingen
city: Hannover
country: Germany
facility: Klinik für Dermatologie und Venerologie
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Luedenscheid
country: Germany
facility: Dr. Renzo Bause Praxis
city: Mahlow
country: Germany
facility: Fachartzpraxis für Dermatologie, Allergologie, Lasermedizin
city: Vigo
country: Spain
facility: C.S. SERGAS Rosalía de Castro - Enfermero
state: Pontevedra
city: Fuenlabrada
country: Spain
facility: Hospital de Fuenlabrada
Study officials:
affiliation: Aarhus University Hospital
name: Karsten Fogh, MD
role: PRINCIPAL_INVESTIGATOR
References: