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

This study has been completed.
Sponsor:
Information provided by:
ConvaTec Inc.
ClinicalTrials.gov Identifier:
NCT01084577
First received: March 9, 2010
Last updated: February 17, 2011
Last verified: February 2011
  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

  Hide Study Locations
Locations
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 April 22, 2014