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Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers

CompletedNot applicableNCT00627094
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

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
Conditions
  • Leg Ulcers
Interventions
  • Device: Biatain
  • Device: Biatain Ibu
Sponsor
Coloplast A/S
Start date
2008-03
Primary completion
2009-04
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Denmark, France, Germany, Spain
Total sites listed
13

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00627094