AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers
NCT ID: NCT01084577
Last Updated: 2011-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
266 participants
INTERVENTIONAL
2010-01-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Urgotul® Silver
Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
Urgotul® Silver
Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
AQUACEL® Ag
AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
AQUACEL® Ag
AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
Interventions
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AQUACEL® Ag
AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
Urgotul® Silver
Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater.
* Subjects who have a venous leg ulcer (i.e. CEAP classification of C6), with duration less than 24 months and size ranging between 5 cm2-40 cm2 .
* Subjects' leg ulcers will meet at least 3 of the 5 following clinical signs: pain between 2 dressing changes, perilesional skin erythema, oedema, foul odour, and heavy exudation.
* Subjects agree to wear compression therapy daily in combination with the trial dressing.
Exclusion Criteria
* Subjects who have had current local or systemic antibiotics in the week prior to inclusion.
* Subjects whose leg ulcers are clinically infected or erysipelas, malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.
* Subjects who have a progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents or high dose corticosteroids.
* Subjects who have participated in a clinical study within the past 3 months.
* Subjects who are pregnant or breastfeeding (in accordance with the Urgotul® Silver package insert).
18 Years
ALL
No
Sponsors
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ConvaTec Inc.
INDUSTRY
Responsible Party
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Convatec Inc.
Principal Investigators
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Dheerendra Kommala, MD
Role: STUDY_DIRECTOR
ConvaTec Inc.
Locations
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Arhus Universitets Hospital (#47)
Aarhus, , Denmark
Bispebjerg Universitets Hospital (#45)
Copenhagen, , Denmark
Odense Universitets Hospital (#46)
Odense, , Denmark
(#35)
Paris, Neuilly Sur Siene, France
37 Bd Bury (#42)
Angoulême, , France
CH de La Fere, (#44)
La Fère, , France
Clinique des Augustines (#38)
Malestroit, , France
19 rue des Clers (#37)
Metz, , France
Hopital Brocca, 54/56 rue Pascal (#41)
Paris, , France
Centre de Sante (#36)
Paris, , France
Clinique Pasteur (#40)
Toulouse, , France
Praxis Dr Thinesse-Mallwitz (#31)
München, Faustlestr 3, Germany
Hautarztpraxis Dr Klovekorn (#33)
Gilching, Romerstr 4, Germany
Chirurgisches Zentrum Bethanien (#34)
Frankfurt am Main, Usinger Str 5, Germany
Arztin fur Allgemeinmedizin (#30)
München, , Germany
Poradnia Medycyny Paliatywnej, Hospicjum Palium, SK im. Przemienienia Panskiego nr.1(#49)
Poznan, Os. Rusa 25a, Poland
NZoZ SEP-MED (#59)
Warsaw, Ul. Hoza 19, Poland
Centr. Med. Beluga-Med, NZOZ (#53)
Krakow, Ul. Obopolna 4a, Poland
Poradnia Chorob MIKOMED (#55)
Lodz, Ul. Plugowa 51/53, Poland
NZOZ Por. Chrurgiczna (#52)
Strzelce Opolskie, Ul. Powstancow Slaskich 9, Poland
Centr. Diagnostyki Ginek.-Poloz. (#51)
Opole, Ul.1-go Maja 9/69-73, Poland
Szpital Woj.w Bielsku-Bialej (#61)
Bielsko-Biala, ul.Armii Krajowej 101, Poland
Poradnia Chirurgiczna Szpital, Specjalistyczny nr.2 (#50)
Bytom, ul.Batorego 15, Poland
Nzoz Certus (#64)
Lodz, ul.Kopernika 67-69, Poland
Venavita (#63)
Poznan, ul.Kurpiowska 8/5, Poland
Specjal.Pomoc Med.MEDSERVICE (#56)
Zabrze, ul.M.Sklodowskiej-Curie 34, Poland
SPZOZ nr.1 Przyszpitalna Por. (#58)
Rzeszów, ul.Rycerska 4, Poland
Nzoz Serce Sercu (#62)
Mogilany, ul.Sw.Bartlomieja Apostola 21, Poland
CF Centrum Flebologii (#60)
Warsaw, ul.Witosynskiego 5, Poland
SPZOZ UM w Lodzi (#54)
Ul. Narutowicza 96, Łódź Voivodeship, Poland
Vestry Close Health Clinic (#8)
Luton, Bedfordshire, United Kingdom
Chalfont and Gerrards Cross Hospital (#14)
Chalfont Saint Peter, Buckinghamshire, United Kingdom
Wound Healing Research Unit (#1)
Heathpark, Cardiff, United Kingdom
University Hopital (#15)
West Midlands, Coventry, United Kingdom
Hainult Health Centre (#24)
Chigwell, Essex, United Kingdom
Rayleigh Clinic (#19)
Rayleigh, Essex, United Kingdom
Southend University Hopital (#20)
Westcliff-on-Sea, Essex, United Kingdom
Distric Nurses, The Wilson Practice, Alton Health Centre (#9)
Alton, Hampshire, United Kingdom
Fareham College Specialist Leg Care Centre (#13)
Fareham, Hampshire, United Kingdom
Southampton Hospital (#6)
Southampton, Hampshire, United Kingdom
St Mary's Hospital (#7)
Armley, Leeds, United Kingdom
Forest Primary Care Center (#18)
Edmonton, London, United Kingdom
Tissue Viability Service NHS Harrow PCT (#26)
Harrow, Middlesex, United Kingdom
Norwich Community Hospital (#21)
Norwich, Norfolk, United Kingdom
Tissue Viability Service, The Willows, Centre for Health Care (#11)
Weaste, Salford, United Kingdom
Mayday University Hospital Wound Clinic (#10)
Thornton Health, Surrey, United Kingdom
Goldsworth Park Health Centre (022)
Woking, Surrey, United Kingdom
Neath Port Talbot Hospital (#17)
Port Talbot, West Glamorgan, United Kingdom
City Hospital (#12)
Birmingham, West Midlands, United Kingdom
University Hospital (#15)
Coventry, West Midlands, United Kingdom
Cross Street Health Centre (#4)
Dudley, West Midlands, United Kingdom
Solihull Hospital (#5)
Solihull, West Midlands, United Kingdom
Arrowe Park Hospital (#2)
Upton, Wirral, United Kingdom
Tissue Viability Consultancy (#3)
Eastbourne, , United Kingdom
Royal Free Hospital (#23)
London, , United Kingdom
Stourport Health Centre (#16)
Worcestershire, , United Kingdom
Countries
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Other Identifiers
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CW-0142-09-U354
Identifier Type: -
Identifier Source: org_study_id
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