Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers

NCT00627094 | Completed Results

• 1 other identifier: DK143WS
• Study Type: interventional
• Target: 120
• Locations: 4 countries
• Sites: 13

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.

Conditions

Leg Ulcers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain Intensity (PI) Change

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

• Change From Baseline in Ulcer Area

  Change from baseline to end of trial (day 43)

• Adverse Events

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

Study Arms (2)

Biatain Ibu

EXPERIMENTAL

Biatain Ibu

Device: Biatain Ibu

Biatain

ACTIVE COMPARATOR

Biatain

Device: Biatain

Interventions

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.

Also known as: Coloplast Biatain

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.

Also known as: Coloplast Biatain-Ibu

Biatain Ibu

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 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
• 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

You may not qualify if:

• 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 cancer chemotherapeutics
• Concomitant participation in other studies
• Previous participation in this study

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (13)

Aarhus Universitetshospital

Aarhus, 8000, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Odense Universitets Hospital

Odense, 5000, Denmark

Location

CHU de Brest

Arras, 62000, France

Location

CHU de Nancy - Hôpital Fournier

Nancy, 54035, France

Location

Department for Dermatology, University School of Medicine

Essen, 45122, Germany

Location

Georg-August-Universität Göttingen

Göttingen, 37075, Germany

Location

Klinik für Dermatologie und Venerologie

Hanover, 30449, Germany

Location

Universitätsklinikum des Saarlandes

Homburg/Saar, 66421, Germany

Location

Dr. Renzo Bause Praxis

Lüdenscheid, 58511, Germany

Location

Fachartzpraxis für Dermatologie, Allergologie, Lasermedizin

Mahlow, 15831, Germany

Location

C.S. SERGAS Rosalía de Castro - Enfermero

Vigo, Pontevedra, 36201, Spain

Location

Hospital de Fuenlabrada

Fuenlabrada, 28942, Spain

Location

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Scientific Manager
• Organization: Coloplast

dkkg@coloplast.com

+4549113557

Study Officials

• Karsten Fogh, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 29, 2008
• Study Start: March 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 15, 2017
• Results First Posted: February 7, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); DK (3); DE (6); FR (2)