Skip to main content
OpenTrials
Completed

NCT Number: NCT00627094

Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Leg Ulcers Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus Universitetshospital, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biatain

Device

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.

Other names: Coloplast Biatain

Biatain Ibu

Device

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.

Other names: Coloplast Biatain-Ibu

Primary outcomes

  1. Pain Relief

    Time frame: Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)

    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.

Secondary outcomes

  1. Pain Intensity (PI) Change

    Time frame: Change from baseline in Pain Intensity (PI) on day 4 evening

    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).

  2. Change From Baseline in Ulcer Area

    Time frame: Change from baseline to end of trial (day 43)

    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)

  3. Adverse Events

    Time frame: Continuously from start of treatment to end of trial (day 43)

    Number of Adverse events reported which were evaluated to be related or possible related to the device

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 29, 2008
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.