AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers

Phase 4

Completed

• Conditions: Leg Ulcer
• Interventions: Device: Urgotul® Silver; Device: AQUACEL® Ag

• Registration Number: NCT01084577
• Lead Sponsor: ConvaTec Inc.

Brief Summary

A prospective, comparative, randomised study to compare the effects on ulcer healing of AQUACEL® Ag dressing when used for 4 weeks followed by treatment with AQUACEL® for 4 weeks to Urgotul® Silver dressing followed by Urgotul® for 4 weeks on subjects with venous leg ulcers.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-17
• Last Update Posted: 2011-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

• Subjects over 18 years, willing and able to provide written informed consent.
• 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.

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Exclusion Criteria

• Subjects with a history of skin sensitivity to any of the components of the study product.
• 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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Urgotul® Silver	Urgotul® Silver	Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
AQUACEL® Ag	AQUACEL® Ag	AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.

Primary Outcome Measures

Name	Time	Method
Wound area reduction from baseline (relative)	8 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical evolution of the wound	8 weeks	presence of each of the 5 selected clinical signs
Wound closure	8 weeks
Tolerance	8 weeks	occurrence of local adverse events

Trial Locations

Locations (56)

SPZOZ UM w Lodzi (#54); 🇵🇱 ul. Narutowicza 96, Lodz, Poland

Poradnia Medycyny Paliatywnej, Hospicjum Palium, SK im. Przemienienia Panskiego nr.1(#49); 🇵🇱 Poznan, Os. Rusa 25a, Poland

Poradnia Chorob MIKOMED (#55); 🇵🇱 Lodz, ul. Plugowa 51/53, Poland

Arztin fur Allgemeinmedizin (#30); 🇩🇪 Munchen, Germany

Clinique Pasteur (#40); 🇫🇷 Toulouse, France

Praxis Dr Thinesse-Mallwitz (#31); 🇩🇪 Munchen, Faustlestr 3, Germany

Clinique des Augustines (#38); 🇫🇷 Malestroit, France

(#35); 🇫🇷 Paris, Neuilly sur Siene, France

Centr. Diagnostyki Ginek.-Poloz. (#51); 🇵🇱 Opole, ul.1-go Maja 9/69-73, Poland

Hautarztpraxis Dr Klovekorn (#33); 🇩🇪 Gilching, Romerstr 4, Germany

37 Bd Bury (#42); 🇫🇷 Angouleme, France

CH de La Fere, (#44); 🇫🇷 La Fere, France

Chirurgisches Zentrum Bethanien (#34); 🇩🇪 Frankfurt/Main, Usinger Str 5, Germany

Odense Universitets Hospital (#46); 🇩🇰 Odense, Denmark

Hopital Brocca, 54/56 rue Pascal (#41); 🇫🇷 Paris, France

19 rue des Clers (#37); 🇫🇷 Metz, France

Centre de Sante (#36); 🇫🇷 Paris, France

Centr. Med. Beluga-Med, NZOZ (#53); 🇵🇱 Krakow, ul. Obopolna 4a, Poland

NZoZ SEP-MED (#59); 🇵🇱 Warszawa, ul. Hoza 19, Poland

NZOZ Por. Chrurgiczna (#52); 🇵🇱 Strzelce Opolskie, ul. Powstancow Slaskich 9, 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); 🇵🇱 Rzeszow, ul.Rycerska 4, Poland

Nzoz Serce Sercu (#62); 🇵🇱 Mogilany, ul.Sw.Bartlomieja Apostola 21, Poland

Vestry Close Health Clinic (#8); 🇬🇧 Luton, Bedfordshire, United Kingdom

CF Centrum Flebologii (#60); 🇵🇱 Warszawa, ul.Witosynskiego 5, Poland

University Hopital (#15); 🇬🇧 West Midlands, Coventry, United Kingdom

Wound Healing Research Unit (#1); 🇬🇧 Heath Park, Cardiff, United Kingdom

Fareham College Specialist Leg Care Centre (#13); 🇬🇧 Fareham, Hampshire, United Kingdom

Distric Nurses, The Wilson Practice, Alton Health Centre (#9); 🇬🇧 Alton, Hampshire, United Kingdom

St Mary's Hospital (#7); 🇬🇧 Armley, Leeds, United Kingdom

Southampton Hospital (#6); 🇬🇧 Southampton, Hampshire, 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

Southend University Hopital (#20); 🇬🇧 Westcliff-on-Sea, Essex, United Kingdom

Chalfont and Gerrards Cross Hospital (#14); 🇬🇧 Chalfont St Peter, Buckinghamshire, United Kingdom

Hainult Health Centre (#24); 🇬🇧 Chigwell, Essex, United Kingdom

Rayleigh Clinic (#19); 🇬🇧 Rayleigh, Essex, United Kingdom

Arhus Universitets Hospital (#47); 🇩🇰 Arhus, Denmark

Bispebjerg Universitets Hospital (#45); 🇩🇰 Copenhagen, Denmark