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

February 17, 2011 updated by: ConvaTec Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

266

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Arhus, Denmark, 8000
        • Arhus Universitets Hospital (#47)
      • Copenhagen, Denmark, 2400
        • Bispebjerg Universitets Hospital (#45)
      • Odense, Denmark, 5000
        • Odense Universitets Hospital (#46)
  • France
      • Angouleme, France, 16 000
        • 37 Bd Bury (#42)
      • La Fere, France, 02800
        • CH de La Fere, (#44)
      • Malestroit, France, BP 23 56140
        • Clinique des Augustines (#38)
      • Metz, France, 57000
        • 19 rue des Clers (#37)
      • Paris, France, 75013
        • Hopital Brocca, 54/56 rue Pascal (#41)
      • Paris, France, 75019
        • Centre de Sante (#36)
      • Toulouse, France, 31 000
        • Clinique Pasteur (#40)
    • Neuilly sur Siene
      • Paris, Neuilly sur Siene, France, 92200
        • (#35)
  • Germany
      • Munchen, Germany, 81667
        • Arztin fur Allgemeinmedizin (#30)
    • Faustlestr 3
      • Munchen, Faustlestr 3, Germany, 80339
        • Praxis Dr Thinesse-Mallwitz (#31)
    • Romerstr 4
      • Gilching, Romerstr 4, Germany, 82205
        • Hautarztpraxis Dr Klovekorn (#33)
    • Usinger Str 5
      • Frankfurt/Main, Usinger Str 5, Germany, 60389
        • Chirurgisches Zentrum Bethanien (#34)
  • Poland
    • Lodz
      • ul. Narutowicza 96, Lodz, Poland, 90-151
        • SPZOZ UM w Lodzi (#54)
    • Os. Rusa 25a
      • Poznan, Os. Rusa 25a, Poland, 61-240
        • Poradnia Medycyny Paliatywnej, Hospicjum Palium, SK im. Przemienienia Panskiego nr.1(#49)
    • ul. Hoza 19
      • Warszawa, ul. Hoza 19, Poland, 00-521
        • NZoZ SEP-MED (#59)
    • ul. Obopolna 4a
      • Krakow, ul. Obopolna 4a, Poland, 30-069
        • Centr. Med. Beluga-Med, NZOZ (#53)
    • ul. Plugowa 51/53
      • Lodz, ul. Plugowa 51/53, Poland, 94-236
        • Poradnia Chorob MIKOMED (#55)
    • ul. Powstancow Slaskich 9
      • Strzelce Opolskie, ul. Powstancow Slaskich 9, Poland, 47-100
        • NZOZ Por. Chrurgiczna (#52)
    • ul.1-go Maja 9/69-73
      • Opole, ul.1-go Maja 9/69-73, Poland, 45-068
        • Centr. Diagnostyki Ginek.-Poloz. (#51)
    • ul.Armii Krajowej 101
      • Bielsko-Biala, ul.Armii Krajowej 101, Poland, 43-316
        • Szpital Woj.w Bielsku-Bialej (#61)
    • ul.Batorego 15
      • Bytom, ul.Batorego 15, Poland, 41-902
        • Poradnia Chirurgiczna Szpital, Specjalistyczny nr.2 (#50)
    • ul.Kopernika 67-69
      • Lodz, ul.Kopernika 67-69, Poland, 90-553
        • Nzoz Certus (#64)
    • ul.Kurpiowska 8/5
      • Poznan, ul.Kurpiowska 8/5, Poland, 60-602
        • Venavita (#63)
    • ul.M.Sklodowskiej-Curie 34
      • Zabrze, ul.M.Sklodowskiej-Curie 34, Poland, 41-800
        • Specjal.Pomoc Med.MEDSERVICE (#56)
    • ul.Rycerska 4
      • Rzeszow, ul.Rycerska 4, Poland, 35-241
        • SPZOZ nr.1 Przyszpitalna Por. (#58)
    • ul.Sw.Bartlomieja Apostola 21
      • Mogilany, ul.Sw.Bartlomieja Apostola 21, Poland, 32-031
        • Nzoz Serce Sercu (#62)
    • ul.Witosynskiego 5
      • Warszawa, ul.Witosynskiego 5, Poland, 03-983
        • CF Centrum Flebologii (#60)
  • United Kingdom
      • Eastbourne, United Kingdom, BN21 4RL
        • Tissue Viability Consultancy (#3)
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital (#23)
      • Worcestershire, United Kingdom, DY13 8EH
        • Stourport Health Centre (#16)
    • Bedfordshire
      • Luton, Bedfordshire, United Kingdom, LU1 AR
        • Vestry Close Health Clinic (#8)
    • Buckinghamshire
      • Chalfont St Peter, Buckinghamshire, United Kingdom, SL9 9DR
        • Chalfont and Gerrards Cross Hospital (#14)
    • Cardiff
      • Heath Park, Cardiff, United Kingdom, CF 14 4XN
        • Wound Healing Research Unit (#1)
    • Coventry
      • West Midlands, Coventry, United Kingdom, CV2 2DX
        • University Hopital (#15)
    • Essex
      • Chigwell, Essex, United Kingdom, IG7 4DF
        • Hainult Health Centre (#24)
      • Rayleigh, Essex, United Kingdom, SS6 7JP
        • Rayleigh Clinic (#19)
      • Westcliff-on-Sea, Essex, United Kingdom, SSO ORY
        • Southend University Hopital (#20)
    • Hampshire
      • Alton, Hampshire, United Kingdom, GU34 2QX
        • Distric Nurses, The Wilson Practice, Alton Health Centre (#9)
      • Fareham, Hampshire, United Kingdom, PO14 1NH
        • Fareham College Specialist Leg Care Centre (#13)
      • Southampton, Hampshire, United Kingdom, S016 6YD
        • Southampton Hospital (#6)
    • Leeds
      • Armley, Leeds, United Kingdom, LS12 3QE
        • St Mary's Hospital (#7)
    • London
      • Edmonton, London, United Kingdom, N9 7HD
        • Forest Primary Care Center (#18)
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 4UQ
        • Tissue Viability Service NHS Harrow PCT (#26)
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR2 3TU
        • Norwich Community Hospital (#21)
    • Salford
      • Weaste, Salford, United Kingdom, M5 2JR
        • Tissue Viability Service, The Willows, Centre for Health Care (#11)
    • Surrey
      • Thornton Health, Surrey, United Kingdom, CR7 7YE
        • Mayday University Hospital Wound Clinic (#10)
      • Woking, Surrey, United Kingdom, GU21 3LQ
        • Goldsworth Park Health Centre (022)
    • West Glamorgan
      • Port Talbot, West Glamorgan, United Kingdom, SA12 7BX
        • Neath Port Talbot Hospital (#17)
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B18 7QH
        • City Hospital (#12)
      • Coventry, West Midlands, United Kingdom, CV2 2DX
        • University Hospital (#15)
      • Dudley, West Midlands, United Kingdom, DY1 1RN
        • Cross Street Health Centre (#4)
      • Solihull, West Midlands, United Kingdom, B91 2JL
        • Solihull Hospital (#5)
    • Wirral
      • Upton, Wirral, United Kingdom, CH49 5PE
        • Arrowe Park Hospital (#2)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wound area reduction from baseline (relative)
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound closure
Time Frame: 8 weeks
8 weeks
Clinical evolution of the wound
Time Frame: 8 weeks
presence of each of the 5 selected clinical signs
8 weeks
Tolerance
Time Frame: 8 weeks
occurrence of local adverse events
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ConvaTec Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

March 9, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (Estimate)

March 10, 2010

Study Record Updates

Last Update Posted (Estimate)

February 21, 2011

Last Update Submitted That Met QC Criteria

February 17, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CW-0142-09-U354

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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