Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers

Coloplast

Status

Completed

Conditions

Leg Ulcers

Treatments

Device: Biatain

Device: Biatain Ibu

Study type

Interventional

Funder types

Industry

Identifiers

NCT00627094

DK143WS

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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