Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers

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

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 Overview

• Status: Completed
• Conditions: Leg Ulcers
• Intervention / Treatment: Device: Biatain Ibu; Device: Biatain

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus Universitetshospital
  • Copenhagen, Denmark, 2400
    • Bispebjerg Hospital
  • Odense, Denmark, 5000
    • Odense Universitets Hospital
• France
  • Arras, France, 62000
    • CHU de Brest
  • Nancy Cedex, France, 54035
    • CHU de Nancy - Hôpital Fournier
• Germany
  • Essen, Germany, 45122
    • Department for Dermatology, University School of Medicine
  • Göttingen, Germany, 37075
    • Georg-August-Universität Göttingen
  • Hannover, Germany, 30449
    • Klinik für Dermatologie und Venerologie
  • Homburg/Saar, Germany, 66421
    • Universitätsklinikum des Saarlandes
  • Luedenscheid, Germany, 58511
    • Dr. Renzo Bause Praxis
  • Mahlow, Germany, 15831
    • Fachartzpraxis für Dermatologie, Allergologie, Lasermedizin
• Spain
  • Fuenlabrada, Spain, 28942
    • Hospital De Fuenlabrada
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36201
      • C.S. SERGAS Rosalía de Castro - Enfermero

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biatain Ibu	Device: Biatain Ibu; 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
Active Comparator: Biatain	Device: Biatain; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Relief	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.	Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity (PI) Change	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).	Change from baseline in Pain Intensity (PI) on day 4 evening
Change From Baseline in Ulcer Area	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)	Change from baseline to end of trial (day 43)
Adverse Events	Number of Adverse events reported which were evaluated to be related or possible related to the device	Continuously from start of treatment to end of trial (day 43)

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Karsten Fogh, MD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: February 20, 2008
• First Submitted That Met QC Criteria: February 20, 2008
• First Posted (Estimate): February 29, 2008

Study Record Updates

• Last Update Posted (Actual): September 15, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: DK143WS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No