Clinical trial NCT01084577: AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Leg Ulcer
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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).

Primary outcomes:
measure: Wound area reduction from baseline (relative)
timeFrame: 8 weeks
Secondary outcomes:
measure: Wound closure
timeFrame: 8 weeks
measure: Clinical evolution of the wound
timeFrame: 8 weeks
measure: Tolerance
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Arhus
country: Denmark
facility: Arhus Universitets Hospital (#47)
city: Copenhagen
country: Denmark
facility: Bispebjerg Universitets Hospital (#45)
city: Odense
country: Denmark
facility: Odense Universitets Hospital (#46)
city: Paris
country: France
facility: (#35)
state: Neuilly sur Siene
city: Angouleme
country: France
facility: 37 Bd Bury (#42)
city: La Fere
country: France
facility: CH de La Fere, (#44)
city: Malestroit
country: France
facility: Clinique des Augustines (#38)
city: Metz
country: France
facility: 19 rue des Clers (#37)
city: Paris
country: France
facility: Hopital Brocca, 54/56 rue Pascal (#41)
city: Paris
country: France
facility: Centre de Sante (#36)
city: Toulouse
country: France
facility: Clinique Pasteur (#40)
city: Munchen
country: Germany
facility: Praxis Dr Thinesse-Mallwitz (#31)
state: Faustlestr 3
city: Gilching
country: Germany
facility: Hautarztpraxis Dr Klovekorn (#33)
state: Romerstr 4
city: Frankfurt/Main
country: Germany
facility: Chirurgisches Zentrum Bethanien (#34)
state: Usinger Str 5
city: Munchen
country: Germany
facility: Arztin fur Allgemeinmedizin (#30)
city: ul. Narutowicza 96
country: Poland
facility: SPZOZ UM w Lodzi (#54)
state: Lodz
city: Poznan
country: Poland
facility: Poradnia Medycyny Paliatywnej, Hospicjum Palium, SK im. Przemienienia Panskiego nr.1(#49)
state: Os. Rusa 25a
city: Warszawa
country: Poland
facility: NZoZ SEP-MED (#59)
state: ul. Hoza 19
city: Krakow
country: Poland
facility: Centr. Med. Beluga-Med, NZOZ (#53)
state: ul. Obopolna 4a
city: Lodz
country: Poland
facility: Poradnia Chorob MIKOMED (#55)
state: ul. Plugowa 51/53
city: Strzelce Opolskie
country: Poland
facility: NZOZ Por. Chrurgiczna (#52)
state: ul. Powstancow Slaskich 9
city: Opole
country: Poland
facility: Centr. Diagnostyki Ginek.-Poloz. (#51)
state: ul.1-go Maja 9/69-73
city: Bielsko-Biala
country: Poland
facility: Szpital Woj.w Bielsku-Bialej (#61)
state: ul.Armii Krajowej 101
city: Bytom
country: Poland
facility: Poradnia Chirurgiczna Szpital, Specjalistyczny nr.2 (#50)
state: ul.Batorego 15
city: Lodz
country: Poland
facility: Nzoz Certus (#64)
state: ul.Kopernika 67-69
city: Poznan
country: Poland
facility: Venavita (#63)
state: ul.Kurpiowska 8/5
city: Zabrze
country: Poland
facility: Specjal.Pomoc Med.MEDSERVICE (#56)
state: ul.M.Sklodowskiej-Curie 34
city: Rzeszow
country: Poland
facility: SPZOZ nr.1 Przyszpitalna Por. (#58)
state: ul.Rycerska 4
city: Mogilany
country: Poland
facility: Nzoz Serce Sercu (#62)
state: ul.Sw.Bartlomieja Apostola 21
city: Warszawa
country: Poland
facility: CF Centrum Flebologii (#60)
state: ul.Witosynskiego 5
city: Luton
country: United Kingdom
facility: Vestry Close Health Clinic (#8)
state: Bedfordshire
city: Chalfont St Peter
country: United Kingdom
facility: Chalfont and Gerrards Cross Hospital (#14)
state: Buckinghamshire
city: Heath Park
country: United Kingdom
facility: Wound Healing Research Unit (#1)
state: Cardiff
city: West Midlands
country: United Kingdom
facility: University Hopital (#15)
state: Coventry
city: Chigwell
country: United Kingdom
facility: Hainult Health Centre (#24)
state: Essex
city: Rayleigh
country: United Kingdom
facility: Rayleigh Clinic (#19)
state: Essex
city: Westcliff-on-Sea
country: United Kingdom
facility: Southend University Hopital (#20)
state: Essex
city: Alton
country: United Kingdom
facility: Distric Nurses, The Wilson Practice, Alton Health Centre (#9)
state: Hampshire
city: Fareham
country: United Kingdom
facility: Fareham College Specialist Leg Care Centre (#13)
state: Hampshire
city: Southampton
country: United Kingdom
facility: Southampton Hospital (#6)
state: Hampshire
city: Armley
country: United Kingdom
facility: St Mary's Hospital (#7)
state: Leeds
city: Edmonton
country: United Kingdom
facility: Forest Primary Care Center (#18)
state: London
city: Harrow
country: United Kingdom
facility: Tissue Viability Service NHS Harrow PCT (#26)
state: Middlesex
city: Norwich
country: United Kingdom
facility: Norwich Community Hospital (#21)
state: Norfolk
city: Weaste
country: United Kingdom
facility: Tissue Viability Service, The Willows, Centre for Health Care (#11)
state: Salford
city: Thornton Health
country: United Kingdom
facility: Mayday University Hospital Wound Clinic (#10)
state: Surrey
city: Woking
country: United Kingdom
facility: Goldsworth Park Health Centre (022)
state: Surrey
city: Port Talbot
country: United Kingdom
facility: Neath Port Talbot Hospital (#17)
state: West Glamorgan
city: Birmingham
country: United Kingdom
facility: City Hospital (#12)
state: West Midlands
city: Coventry
country: United Kingdom
facility: University Hospital (#15)
state: West Midlands
city: Dudley
country: United Kingdom
facility: Cross Street Health Centre (#4)
state: West Midlands
city: Solihull
country: United Kingdom
facility: Solihull Hospital (#5)
state: West Midlands
city: Upton
country: United Kingdom
facility: Arrowe Park Hospital (#2)
state: Wirral
city: Eastbourne
country: United Kingdom
facility: Tissue Viability Consultancy (#3)
city: London
country: United Kingdom
facility: Royal Free Hospital (#23)
city: Worcestershire
country: United Kingdom
facility: Stourport Health Centre (#16)
Study officials:
affiliation: ConvaTec Inc.
name: Dheerendra Kommala, MD
role: STUDY_DIRECTOR
References: