Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers

Not Applicable

Completed

• Conditions: Leg Ulcers
• Interventions: Device: Biatain; Device: Biatain Ibu

• Registration Number: NCT00627094
• Lead Sponsor: Coloplast A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-02-20
• Study First Posted: 2008-02-29
• Study Start: 2008-03
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2015-09-03
• Results First Submitted QC: 2016-12-14
• Results First Posted: 2017-02-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biatain	Biatain	Biatain
Biatain Ibu	Biatain Ibu	Biatain Ibu

Primary Outcome Measures

Name	Time	Method
Pain Relief	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 Outcome Measures

Name	Time	Method
Pain Intensity (PI) Change	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).
Change From Baseline in Ulcer Area	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)
Adverse Events	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

Trial Locations

Locations (13)

CHU de Nancy - Hôpital Fournier; 🇫🇷 Nancy Cedex, France

Department for Dermatology, University School of Medicine; 🇩🇪 Essen, Germany

Dr. Renzo Bause Praxis; 🇩🇪 Luedenscheid, Germany

Hospital de Fuenlabrada; 🇪🇸 Fuenlabrada, Spain

Aarhus Universitetshospital; 🇩🇰 Aarhus, Denmark

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Fachartzpraxis für Dermatologie, Allergologie, Lasermedizin; 🇩🇪 Mahlow, Germany

Odense Universitets Hospital; 🇩🇰 Odense, Denmark

CHU de Brest; 🇫🇷 Arras, France

Klinik für Dermatologie und Venerologie; 🇩🇪 Hannover, Germany

Georg-August-Universität Göttingen; 🇩🇪 Göttingen, Germany

Universitätsklinikum des Saarlandes; 🇩🇪 Homburg/Saar, Germany

C.S. SERGAS Rosalía de Castro - Enfermero; 🇪🇸 Vigo, Pontevedra, Spain