Leg Ulcer Clinical Trial
Official title:
A Prospective, Multi-centre, Randomized, Open-label, Parallel, Comparative Study to Evaluate Effects of AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers
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.
| Status | Completed |
| Enrollment | 266 |
| Est. completion date | January 2011 |
| Est. primary completion date | January 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. 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). |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Arhus Universitets Hospital (#47) | Arhus | |
| Denmark | Bispebjerg Universitets Hospital (#45) | Copenhagen | |
| Denmark | Odense Universitets Hospital (#46) | Odense | |
| France | 37 Bd Bury (#42) | Angouleme | |
| France | CH de La Fere, (#44) | La Fere | |
| France | Clinique des Augustines (#38) | Malestroit | |
| France | 19 rue des Clers (#37) | Metz | |
| France | (#35) | Paris | Neuilly sur Siene |
| France | Centre de Sante (#36) | Paris | |
| France | Hopital Brocca, 54/56 rue Pascal (#41) | Paris | |
| France | Clinique Pasteur (#40) | Toulouse | |
| Germany | Chirurgisches Zentrum Bethanien (#34) | Frankfurt/Main | Usinger Str 5 |
| Germany | Hautarztpraxis Dr Klovekorn (#33) | Gilching | Romerstr 4 |
| Germany | Arztin fur Allgemeinmedizin (#30) | Munchen | |
| Germany | Praxis Dr Thinesse-Mallwitz (#31) | Munchen | Faustlestr 3 |
| 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 | Centr. Med. Beluga-Med, NZOZ (#53) | Krakow | ul. Obopolna 4a |
| Poland | Nzoz Certus (#64) | Lodz | ul.Kopernika 67-69 |
| Poland | Poradnia Chorob MIKOMED (#55) | Lodz | ul. Plugowa 51/53 |
| Poland | Nzoz Serce Sercu (#62) | Mogilany | ul.Sw.Bartlomieja Apostola 21 |
| Poland | Centr. Diagnostyki Ginek.-Poloz. (#51) | Opole | ul.1-go Maja 9/69-73 |
| Poland | Poradnia Medycyny Paliatywnej, Hospicjum Palium, SK im. Przemienienia Panskiego nr.1(#49) | Poznan | Os. Rusa 25a |
| Poland | Venavita (#63) | Poznan | ul.Kurpiowska 8/5 |
| Poland | SPZOZ nr.1 Przyszpitalna Por. (#58) | Rzeszow | ul.Rycerska 4 |
| Poland | NZOZ Por. Chrurgiczna (#52) | Strzelce Opolskie | ul. Powstancow Slaskich 9 |
| Poland | SPZOZ UM w Lodzi (#54) | ul. Narutowicza 96 | Lodz |
| Poland | CF Centrum Flebologii (#60) | Warszawa | ul.Witosynskiego 5 |
| Poland | NZoZ SEP-MED (#59) | Warszawa | ul. Hoza 19 |
| Poland | Specjal.Pomoc Med.MEDSERVICE (#56) | Zabrze | ul.M.Sklodowskiej-Curie 34 |
| United Kingdom | Distric Nurses, The Wilson Practice, Alton Health Centre (#9) | Alton | Hampshire |
| United Kingdom | St Mary's Hospital (#7) | Armley | Leeds |
| United Kingdom | City Hospital (#12) | Birmingham | West Midlands |
| United Kingdom | Chalfont and Gerrards Cross Hospital (#14) | Chalfont St Peter | Buckinghamshire |
| United Kingdom | Hainult Health Centre (#24) | Chigwell | Essex |
| United Kingdom | University Hospital (#15) | Coventry | West Midlands |
| United Kingdom | Cross Street Health Centre (#4) | Dudley | West Midlands |
| United Kingdom | Tissue Viability Consultancy (#3) | Eastbourne | |
| United Kingdom | Forest Primary Care Center (#18) | Edmonton | London |
| United Kingdom | Fareham College Specialist Leg Care Centre (#13) | Fareham | Hampshire |
| United Kingdom | Tissue Viability Service NHS Harrow PCT (#26) | Harrow | Middlesex |
| United Kingdom | Wound Healing Research Unit (#1) | Heath Park | Cardiff |
| United Kingdom | Royal Free Hospital (#23) | London | |
| United Kingdom | Vestry Close Health Clinic (#8) | Luton | Bedfordshire |
| United Kingdom | Norwich Community Hospital (#21) | Norwich | Norfolk |
| United Kingdom | Neath Port Talbot Hospital (#17) | Port Talbot | West Glamorgan |
| United Kingdom | Rayleigh Clinic (#19) | Rayleigh | Essex |
| United Kingdom | Solihull Hospital (#5) | Solihull | West Midlands |
| United Kingdom | Southampton Hospital (#6) | Southampton | Hampshire |
| United Kingdom | Mayday University Hospital Wound Clinic (#10) | Thornton Health | Surrey |
| United Kingdom | Arrowe Park Hospital (#2) | Upton | Wirral |
| United Kingdom | Tissue Viability Service, The Willows, Centre for Health Care (#11) | Weaste | Salford |
| United Kingdom | University Hopital (#15) | West Midlands | Coventry |
| United Kingdom | Southend University Hopital (#20) | Westcliff-on-Sea | Essex |
| United Kingdom | Goldsworth Park Health Centre (022) | Woking | Surrey |
| United Kingdom | Stourport Health Centre (#16) | Worcestershire |
| Lead Sponsor | Collaborator |
|---|---|
| ConvaTec Inc. |
Denmark, France, Germany, Poland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Wound area reduction from baseline (relative) | 8 weeks | No | |
| Secondary | Wound closure | 8 weeks | No | |
| Secondary | Clinical evolution of the wound | presence of each of the 5 selected clinical signs | 8 weeks | No |
| Secondary | Tolerance | occurrence of local adverse events | 8 weeks | No |
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