AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers
This study has been completed.
Sponsor:
ConvaTec Inc.
Information provided by:
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT01084577
First received: March 9, 2010
Last updated: February 17, 2011
Last verified: February 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leg Ulcer |
Device: AQUACEL® Ag Device: Urgotul® Silver |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by ConvaTec Inc.:
Primary Outcome Measures:
- Wound area reduction from baseline (relative) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Wound closure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Clinical evolution of the wound [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]presence of each of the 5 selected clinical signs
- Tolerance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]occurrence of local adverse events
| Estimated Enrollment: | 266 |
| Study Start Date: | January 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Urgotul® Silver
Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
|
Device: Urgotul® Silver
Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
|
|
Active Comparator: AQUACEL® Ag
AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
|
Device: AQUACEL® Ag
AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084577
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Hide Study LocationsLocations
| Denmark | |
| Arhus Universitets Hospital (#47) | |
| Arhus, Denmark, 8000 | |
| Bispebjerg Universitets Hospital (#45) | |
| Copenhagen, Denmark, 2400 | |
| Odense Universitets Hospital (#46) | |
| Odense, Denmark, 5000 | |
| France | |
| (#35) | |
| Paris, Neuilly sur Siene, France, 92200 | |
| 37 Bd Bury (#42) | |
| Angouleme, France, 16 000 | |
| CH de La Fere, (#44) | |
| La Fere, France, 02800 | |
| Clinique des Augustines (#38) | |
| Malestroit, France, BP 23 56140 | |
| 19 rue des Clers (#37) | |
| Metz, France, 57000 | |
| Hopital Brocca, 54/56 rue Pascal (#41) | |
| Paris, France, 75013 | |
| Centre de Sante (#36) | |
| Paris, France, 75019 | |
| Clinique Pasteur (#40) | |
| Toulouse, France, 31 000 | |
| Germany | |
| Praxis Dr Thinesse-Mallwitz (#31) | |
| Munchen, Faustlestr 3, Germany, 80339 | |
| Hautarztpraxis Dr Klovekorn (#33) | |
| Gilching, Romerstr 4, Germany, 82205 | |
| Chirurgisches Zentrum Bethanien (#34) | |
| Frankfurt/Main, Usinger Str 5, Germany, 60389 | |
| Arztin fur Allgemeinmedizin (#30) | |
| Munchen, Germany, 81667 | |
| Poland | |
| SPZOZ UM w Lodzi (#54) | |
| ul. Narutowicza 96, Lodz, Poland, 90-151 | |
| Poradnia Medycyny Paliatywnej, Hospicjum Palium, SK im. Przemienienia Panskiego nr.1(#49) | |
| Poznan, Os. Rusa 25a, Poland, 61-240 | |
| NZoZ SEP-MED (#59) | |
| Warszawa, ul. Hoza 19, Poland, 00-521 | |
| Centr. Med. Beluga-Med, NZOZ (#53) | |
| Krakow, ul. Obopolna 4a, Poland, 30-069 | |
| Poradnia Chorob MIKOMED (#55) | |
| Lodz, ul. Plugowa 51/53, Poland, 94-236 | |
| NZOZ Por. Chrurgiczna (#52) | |
| Strzelce Opolskie, ul. Powstancow Slaskich 9, Poland, 47-100 | |
| Centr. Diagnostyki Ginek.-Poloz. (#51) | |
| Opole, ul.1-go Maja 9/69-73, Poland, 45-068 | |
| Szpital Woj.w Bielsku-Bialej (#61) | |
| Bielsko-Biala, ul.Armii Krajowej 101, Poland, 43-316 | |
| Poradnia Chirurgiczna Szpital, Specjalistyczny nr.2 (#50) | |
| Bytom, ul.Batorego 15, Poland, 41-902 | |
| Nzoz Certus (#64) | |
| Lodz, ul.Kopernika 67-69, Poland, 90-553 | |
| Venavita (#63) | |
| Poznan, ul.Kurpiowska 8/5, Poland, 60-602 | |
| Specjal.Pomoc Med.MEDSERVICE (#56) | |
| Zabrze, ul.M.Sklodowskiej-Curie 34, Poland, 41-800 | |
| SPZOZ nr.1 Przyszpitalna Por. (#58) | |
| Rzeszow, ul.Rycerska 4, Poland, 35-241 | |
| Nzoz Serce Sercu (#62) | |
| Mogilany, ul.Sw.Bartlomieja Apostola 21, Poland, 32-031 | |
| CF Centrum Flebologii (#60) | |
| Warszawa, ul.Witosynskiego 5, Poland, 03-983 | |
| United Kingdom | |
| Vestry Close Health Clinic (#8) | |
| Luton, Bedfordshire, United Kingdom, LU1 AR | |
| Chalfont and Gerrards Cross Hospital (#14) | |
| Chalfont St Peter, Buckinghamshire, United Kingdom, SL9 9DR | |
| Wound Healing Research Unit (#1) | |
| Heath Park, Cardiff, United Kingdom, CF 14 4XN | |
| University Hopital (#15) | |
| West Midlands, Coventry, United Kingdom, CV2 2DX | |
| Hainult Health Centre (#24) | |
| Chigwell, Essex, United Kingdom, IG7 4DF | |
| Rayleigh Clinic (#19) | |
| Rayleigh, Essex, United Kingdom, SS6 7JP | |
| Southend University Hopital (#20) | |
| Westcliff-on-Sea, Essex, United Kingdom, SSO ORY | |
| Distric Nurses, The Wilson Practice, Alton Health Centre (#9) | |
| Alton, Hampshire, United Kingdom, GU34 2QX | |
| Fareham College Specialist Leg Care Centre (#13) | |
| Fareham, Hampshire, United Kingdom, PO14 1NH | |
| Southampton Hospital (#6) | |
| Southampton, Hampshire, United Kingdom, S016 6YD | |
| St Mary's Hospital (#7) | |
| Armley, Leeds, United Kingdom, LS12 3QE | |
| Forest Primary Care Center (#18) | |
| Edmonton, London, United Kingdom, N9 7HD | |
| Tissue Viability Service NHS Harrow PCT (#26) | |
| Harrow, Middlesex, United Kingdom, HA1 4UQ | |
| Norwich Community Hospital (#21) | |
| Norwich, Norfolk, United Kingdom, NR2 3TU | |
| Tissue Viability Service, The Willows, Centre for Health Care (#11) | |
| Weaste, Salford, United Kingdom, M5 2JR | |
| Mayday University Hospital Wound Clinic (#10) | |
| Thornton Health, Surrey, United Kingdom, CR7 7YE | |
| Goldsworth Park Health Centre (022) | |
| Woking, Surrey, United Kingdom, GU21 3LQ | |
| Neath Port Talbot Hospital (#17) | |
| Port Talbot, West Glamorgan, United Kingdom, SA12 7BX | |
| City Hospital (#12) | |
| Birmingham, West Midlands, United Kingdom, B18 7QH | |
| University Hospital (#15) | |
| Coventry, West Midlands, United Kingdom, CV2 2DX | |
| Cross Street Health Centre (#4) | |
| Dudley, West Midlands, United Kingdom, DY1 1RN | |
| Solihull Hospital (#5) | |
| Solihull, West Midlands, United Kingdom, B91 2JL | |
| Arrowe Park Hospital (#2) | |
| Upton, Wirral, United Kingdom, CH49 5PE | |
| Tissue Viability Consultancy (#3) | |
| Eastbourne, United Kingdom, BN21 4RL | |
| Royal Free Hospital (#23) | |
| London, United Kingdom, NW3 2QG | |
| Stourport Health Centre (#16) | |
| Worcestershire, United Kingdom, DY13 8EH | |
Sponsors and Collaborators
ConvaTec Inc.
Investigators
| Study Director: | Dheerendra Kommala, MD | ConvaTec Inc. |
More Information
No publications provided
| Responsible Party: | Dheerendra Kommala, MD, Convatec Inc. |
| ClinicalTrials.gov Identifier: | NCT01084577 History of Changes |
| Other Study ID Numbers: | CW-0142-09-U354 |
| Study First Received: | March 9, 2010 |
| Last Updated: | February 17, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Poland: Ethics Committee Germany: Ethics Commission Denmark: Ethics Committee |
Additional relevant MeSH terms:
|
Leg Ulcer Ulcer Varicose Ulcer Skin Ulcer Skin Diseases Pathologic Processes Varicose Veins |
Vascular Diseases Cardiovascular Diseases Carboxymethylcellulose Sodium Laxatives Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013