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Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers

Primary Purpose

Leg Ulcers

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Biatain
Biatain Ibu
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aarhus Universitetshospital
  • Bispebjerg Hospital
  • Odense Universitets Hospital
  • CHU de Brest
  • CHU de Nancy - Hôpital Fournier
  • Department for Dermatology, University School of Medicine
  • Georg-August-Universität Göttingen
  • Klinik für Dermatologie und Venerologie
  • Universitätsklinikum des Saarlandes
  • Dr. Renzo Bause Praxis
  • Fachartzpraxis für Dermatologie, Allergologie, Lasermedizin
  • C.S. SERGAS Rosalía de Castro - Enfermero
  • Hospital de Fuenlabrada

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biatain Ibu

Biatain

Arm Description

Biatain Ibu

Biatain

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2008
Last Updated
August 17, 2017
Sponsor
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00627094
Brief Title
Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biatain Ibu
Arm Type
Experimental
Arm Description
Biatain Ibu
Arm Title
Biatain
Arm Type
Active Comparator
Arm Description
Biatain
Intervention Type
Device
Intervention Name(s)
Biatain
Other Intervention Name(s)
Coloplast Biatain
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Biatain Ibu
Other Intervention Name(s)
Coloplast Biatain-Ibu
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Relief
Description
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.
Time Frame
Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)
Secondary Outcome Measure Information:
Title
Pain Intensity (PI) Change
Description
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).
Time Frame
Change from baseline in Pain Intensity (PI) on day 4 evening
Title
Change From Baseline in Ulcer Area
Description
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)
Time Frame
Change from baseline to end of trial (day 43)
Title
Adverse Events
Description
Number of Adverse events reported which were evaluated to be related or possible related to the device
Time Frame
Continuously from start of treatment to end of trial (day 43)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karsten Fogh, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus Universitetshospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Odense Universitets Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
CHU de Brest
City
Arras
ZIP/Postal Code
62000
Country
France
Facility Name
CHU de Nancy - Hôpital Fournier
City
Nancy Cedex
ZIP/Postal Code
54035
Country
France
Facility Name
Department for Dermatology, University School of Medicine
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Georg-August-Universität Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Klinik für Dermatologie und Venerologie
City
Hannover
ZIP/Postal Code
30449
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Dr. Renzo Bause Praxis
City
Luedenscheid
ZIP/Postal Code
58511
Country
Germany
Facility Name
Fachartzpraxis für Dermatologie, Allergologie, Lasermedizin
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
C.S. SERGAS Rosalía de Castro - Enfermero
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36201
Country
Spain
Facility Name
Hospital de Fuenlabrada
City
Fuenlabrada
ZIP/Postal Code
28942
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers

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