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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urgotul® Silver | Active Comparator | Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks. |
|
| AQUACEL® Ag | Active Comparator | AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AQUACEL® Ag | Device | AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound area reduction from baseline (relative) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound closure | 8 weeks | |
| Clinical evolution of the wound | presence of each of the 5 selected clinical signs | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dheerendra Kommala, MD | ConvaTec Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arhus Universitets Hospital (#47) | Aarhus | 8000 | Denmark | |||
| Bispebjerg Universitets Hospital (#45) |
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| Urgotul® Silver | Device | Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks. |
|
| Tolerance |
occurrence of local adverse events |
| 8 weeks |
| Copenhagen |
| 2400 |
| Denmark |
| Odense Universitets Hospital (#46) | Odense | 5000 | Denmark |
| (#35) | Paris | Neuilly Sur Siene | 92200 | France |
| 37 Bd Bury (#42) | Angoulême | 16 000 | France |
| CH de La Fere, (#44) | La Fère | 02800 | France |
| Clinique des Augustines (#38) | Malestroit | BP 23 56140 | France |
| 19 rue des Clers (#37) | Metz | 57000 | France |
| Hopital Brocca, 54/56 rue Pascal (#41) | Paris | 75013 | France |
| Centre de Sante (#36) | Paris | 75019 | France |
| Clinique Pasteur (#40) | Toulouse | 31 000 | France |
| Praxis Dr Thinesse-Mallwitz (#31) | München | Faustlestr 3 | 80339 | Germany |
| Hautarztpraxis Dr Klovekorn (#33) | Gilching | Romerstr 4 | 82205 | Germany |
| Chirurgisches Zentrum Bethanien (#34) | Frankfurt am Main | Usinger Str 5 | 60389 | Germany |
| Arztin fur Allgemeinmedizin (#30) | München | 81667 | Germany |
| Poradnia Medycyny Paliatywnej, Hospicjum Palium, SK im. Przemienienia Panskiego nr.1(#49) | Poznan | Os. Rusa 25a | 61-240 | Poland |
| NZoZ SEP-MED (#59) | Warsaw | Ul. Hoza 19 | 00-521 | Poland |
| Centr. Med. Beluga-Med, NZOZ (#53) | Krakow | Ul. Obopolna 4a | 30-069 | Poland |
| Poradnia Chorob MIKOMED (#55) | Lodz | Ul. Plugowa 51/53 | 94-236 | Poland |
| NZOZ Por. Chrurgiczna (#52) | Strzelce Opolskie | Ul. Powstancow Slaskich 9 | 47-100 | Poland |
| Centr. Diagnostyki Ginek.-Poloz. (#51) | Opole | Ul.1-go Maja 9/69-73 | 45-068 | Poland |
| Szpital Woj.w Bielsku-Bialej (#61) | Bielsko-Biala | ul.Armii Krajowej 101 | 43-316 | Poland |
| Poradnia Chirurgiczna Szpital, Specjalistyczny nr.2 (#50) | Bytom | ul.Batorego 15 | 41-902 | Poland |
| Nzoz Certus (#64) | Lodz | ul.Kopernika 67-69 | 90-553 | Poland |
| Venavita (#63) | Poznan | ul.Kurpiowska 8/5 | 60-602 | Poland |
| Specjal.Pomoc Med.MEDSERVICE (#56) | Zabrze | ul.M.Sklodowskiej-Curie 34 | 41-800 | Poland |
| SPZOZ nr.1 Przyszpitalna Por. (#58) | Rzeszów | ul.Rycerska 4 | 35-241 | Poland |
| Nzoz Serce Sercu (#62) | Mogilany | ul.Sw.Bartlomieja Apostola 21 | 32-031 | Poland |
| CF Centrum Flebologii (#60) | Warsaw | ul.Witosynskiego 5 | 03-983 | Poland |
| SPZOZ UM w Lodzi (#54) | Ul. Narutowicza 96 | Łódź Voivodeship | 90-151 | Poland |
| Vestry Close Health Clinic (#8) | Luton | Bedfordshire | LU1 AR | United Kingdom |
| Chalfont and Gerrards Cross Hospital (#14) | Chalfont Saint Peter | Buckinghamshire | SL9 9DR | United Kingdom |
| Wound Healing Research Unit (#1) | Heathpark | Cardiff | CF 14 4XN | United Kingdom |
| University Hopital (#15) | West Midlands | Coventry | CV2 2DX | United Kingdom |
| Hainult Health Centre (#24) | Chigwell | Essex | IG7 4DF | United Kingdom |
| Rayleigh Clinic (#19) | Rayleigh | Essex | SS6 7JP | United Kingdom |
| Southend University Hopital (#20) | Westcliff-on-Sea | Essex | SSO ORY | United Kingdom |
| Distric Nurses, The Wilson Practice, Alton Health Centre (#9) | Alton | Hampshire | GU34 2QX | United Kingdom |
| Fareham College Specialist Leg Care Centre (#13) | Fareham | Hampshire | PO14 1NH | United Kingdom |
| Southampton Hospital (#6) | Southampton | Hampshire | S016 6YD | United Kingdom |
| St Mary's Hospital (#7) | Armley | Leeds | LS12 3QE | United Kingdom |
| Forest Primary Care Center (#18) | Edmonton | London | N9 7HD | United Kingdom |
| Tissue Viability Service NHS Harrow PCT (#26) | Harrow | Middlesex | HA1 4UQ | United Kingdom |
| Norwich Community Hospital (#21) | Norwich | Norfolk | NR2 3TU | United Kingdom |
| Tissue Viability Service, The Willows, Centre for Health Care (#11) | Weaste | Salford | M5 2JR | United Kingdom |
| Mayday University Hospital Wound Clinic (#10) | Thornton Health | Surrey | CR7 7YE | United Kingdom |
| Goldsworth Park Health Centre (022) | Woking | Surrey | GU21 3LQ | United Kingdom |
| Neath Port Talbot Hospital (#17) | Port Talbot | West Glamorgan | SA12 7BX | United Kingdom |
| City Hospital (#12) | Birmingham | West Midlands | B18 7QH | United Kingdom |
| University Hospital (#15) | Coventry | West Midlands | CV2 2DX | United Kingdom |
| Cross Street Health Centre (#4) | Dudley | West Midlands | DY1 1RN | United Kingdom |
| Solihull Hospital (#5) | Solihull | West Midlands | B91 2JL | United Kingdom |
| Arrowe Park Hospital (#2) | Upton | Wirral | CH49 5PE | United Kingdom |
| Tissue Viability Consultancy (#3) | Eastbourne | BN21 4RL | United Kingdom |
| Royal Free Hospital (#23) | London | NW3 2QG | United Kingdom |
| Stourport Health Centre (#16) | Worcestershire | DY13 8EH | United Kingdom |
| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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