Status:
COMPLETED
Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers
Lead Sponsor:
Coloplast A/S
Conditions:
Leg Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
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
- \>= 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00627094
Start Date
March 1 2008
End Date
April 1 2009
Last Update
September 15 2017
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Aarhus Universitetshospital
Aarhus, Denmark, 8000
2
Bispebjerg Hospital
Copenhagen, Denmark, 2400
3
Odense Universitets Hospital
Odense, Denmark, 5000
4
CHU de Brest
Arras, France, 62000