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

Primary Purpose

Leg Ulcer

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
AQUACEL® Ag
Urgotul® Silver
Sponsored by
ConvaTec Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Arhus Universitets Hospital (#47)
  • Bispebjerg Universitets Hospital (#45)
  • Odense Universitets Hospital (#46)
  • (#35)
  • 37 Bd Bury (#42)
  • CH de La Fere, (#44)
  • Clinique des Augustines (#38)
  • 19 rue des Clers (#37)
  • Hopital Brocca, 54/56 rue Pascal (#41)
  • Centre de Sante (#36)
  • Clinique Pasteur (#40)
  • Praxis Dr Thinesse-Mallwitz (#31)
  • Hautarztpraxis Dr Klovekorn (#33)
  • Chirurgisches Zentrum Bethanien (#34)
  • Arztin fur Allgemeinmedizin (#30)
  • SPZOZ UM w Lodzi (#54)
  • Poradnia Medycyny Paliatywnej, Hospicjum Palium, SK im. Przemienienia Panskiego nr.1(#49)
  • NZoZ SEP-MED (#59)
  • Centr. Med. Beluga-Med, NZOZ (#53)
  • Poradnia Chorob MIKOMED (#55)
  • NZOZ Por. Chrurgiczna (#52)
  • Centr. Diagnostyki Ginek.-Poloz. (#51)
  • Szpital Woj.w Bielsku-Bialej (#61)
  • Poradnia Chirurgiczna Szpital, Specjalistyczny nr.2 (#50)
  • Nzoz Certus (#64)
  • Venavita (#63)
  • Specjal.Pomoc Med.MEDSERVICE (#56)
  • SPZOZ nr.1 Przyszpitalna Por. (#58)
  • Nzoz Serce Sercu (#62)
  • CF Centrum Flebologii (#60)
  • Vestry Close Health Clinic (#8)
  • Chalfont and Gerrards Cross Hospital (#14)
  • Wound Healing Research Unit (#1)
  • University Hopital (#15)
  • Hainult Health Centre (#24)
  • Rayleigh Clinic (#19)
  • Southend University Hopital (#20)
  • Distric Nurses, The Wilson Practice, Alton Health Centre (#9)
  • Fareham College Specialist Leg Care Centre (#13)
  • Southampton Hospital (#6)
  • St Mary's Hospital (#7)
  • Forest Primary Care Center (#18)
  • Tissue Viability Service NHS Harrow PCT (#26)
  • Norwich Community Hospital (#21)
  • Tissue Viability Service, The Willows, Centre for Health Care (#11)
  • Mayday University Hospital Wound Clinic (#10)
  • Goldsworth Park Health Centre (022)
  • Neath Port Talbot Hospital (#17)
  • City Hospital (#12)
  • University Hospital (#15)
  • Cross Street Health Centre (#4)
  • Solihull Hospital (#5)
  • Arrowe Park Hospital (#2)
  • Tissue Viability Consultancy (#3)
  • Royal Free Hospital (#23)
  • Stourport Health Centre (#16)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Urgotul® Silver

AQUACEL® Ag

Arm Description

Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.

AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.

Outcomes

Primary Outcome Measures

Wound area reduction from baseline (relative)

Secondary Outcome Measures

Wound closure
Clinical evolution of the wound
presence of each of the 5 selected clinical signs
Tolerance
occurrence of local adverse events

Full Information

First Posted
March 9, 2010
Last Updated
February 17, 2011
Sponsor
ConvaTec Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01084577
Brief Title
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

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ConvaTec Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
266 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Urgotul® Silver
Arm Type
Active Comparator
Arm Description
Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
Arm Title
AQUACEL® Ag
Arm Type
Active Comparator
Arm Description
AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
Intervention Type
Device
Intervention Name(s)
AQUACEL® Ag
Intervention Description
AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
Intervention Type
Device
Intervention Name(s)
Urgotul® Silver
Intervention Description
Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
Primary Outcome Measure Information:
Title
Wound area reduction from baseline (relative)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Wound closure
Time Frame
8 weeks
Title
Clinical evolution of the wound
Description
presence of each of the 5 selected clinical signs
Time Frame
8 weeks
Title
Tolerance
Description
occurrence of local adverse events
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dheerendra Kommala, MD
Organizational Affiliation
ConvaTec Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arhus Universitets Hospital (#47)
City
Arhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Bispebjerg Universitets Hospital (#45)
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Odense Universitets Hospital (#46)
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
(#35)
City
Paris
State/Province
Neuilly sur Siene
ZIP/Postal Code
92200
Country
France
Facility Name
37 Bd Bury (#42)
City
Angouleme
ZIP/Postal Code
16 000
Country
France
Facility Name
CH de La Fere, (#44)
City
La Fere
ZIP/Postal Code
02800
Country
France
Facility Name
Clinique des Augustines (#38)
City
Malestroit
ZIP/Postal Code
BP 23 56140
Country
France
Facility Name
19 rue des Clers (#37)
City
Metz
ZIP/Postal Code
57000
Country
France
Facility Name
Hopital Brocca, 54/56 rue Pascal (#41)
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Centre de Sante (#36)
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Clinique Pasteur (#40)
City
Toulouse
ZIP/Postal Code
31 000
Country
France
Facility Name
Praxis Dr Thinesse-Mallwitz (#31)
City
Munchen
State/Province
Faustlestr 3
ZIP/Postal Code
80339
Country
Germany
Facility Name
Hautarztpraxis Dr Klovekorn (#33)
City
Gilching
State/Province
Romerstr 4
ZIP/Postal Code
82205
Country
Germany
Facility Name
Chirurgisches Zentrum Bethanien (#34)
City
Frankfurt/Main
State/Province
Usinger Str 5
ZIP/Postal Code
60389
Country
Germany
Facility Name
Arztin fur Allgemeinmedizin (#30)
City
Munchen
ZIP/Postal Code
81667
Country
Germany
Facility Name
SPZOZ UM w Lodzi (#54)
City
ul. Narutowicza 96
State/Province
Lodz
ZIP/Postal Code
90-151
Country
Poland
Facility Name
Poradnia Medycyny Paliatywnej, Hospicjum Palium, SK im. Przemienienia Panskiego nr.1(#49)
City
Poznan
State/Province
Os. Rusa 25a
ZIP/Postal Code
61-240
Country
Poland
Facility Name
NZoZ SEP-MED (#59)
City
Warszawa
State/Province
ul. Hoza 19
ZIP/Postal Code
00-521
Country
Poland
Facility Name
Centr. Med. Beluga-Med, NZOZ (#53)
City
Krakow
State/Province
ul. Obopolna 4a
ZIP/Postal Code
30-069
Country
Poland
Facility Name
Poradnia Chorob MIKOMED (#55)
City
Lodz
State/Province
ul. Plugowa 51/53
ZIP/Postal Code
94-236
Country
Poland
Facility Name
NZOZ Por. Chrurgiczna (#52)
City
Strzelce Opolskie
State/Province
ul. Powstancow Slaskich 9
ZIP/Postal Code
47-100
Country
Poland
Facility Name
Centr. Diagnostyki Ginek.-Poloz. (#51)
City
Opole
State/Province
ul.1-go Maja 9/69-73
ZIP/Postal Code
45-068
Country
Poland
Facility Name
Szpital Woj.w Bielsku-Bialej (#61)
City
Bielsko-Biala
State/Province
ul.Armii Krajowej 101
ZIP/Postal Code
43-316
Country
Poland
Facility Name
Poradnia Chirurgiczna Szpital, Specjalistyczny nr.2 (#50)
City
Bytom
State/Province
ul.Batorego 15
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Nzoz Certus (#64)
City
Lodz
State/Province
ul.Kopernika 67-69
ZIP/Postal Code
90-553
Country
Poland
Facility Name
Venavita (#63)
City
Poznan
State/Province
ul.Kurpiowska 8/5
ZIP/Postal Code
60-602
Country
Poland
Facility Name
Specjal.Pomoc Med.MEDSERVICE (#56)
City
Zabrze
State/Province
ul.M.Sklodowskiej-Curie 34
ZIP/Postal Code
41-800
Country
Poland
Facility Name
SPZOZ nr.1 Przyszpitalna Por. (#58)
City
Rzeszow
State/Province
ul.Rycerska 4
ZIP/Postal Code
35-241
Country
Poland
Facility Name
Nzoz Serce Sercu (#62)
City
Mogilany
State/Province
ul.Sw.Bartlomieja Apostola 21
ZIP/Postal Code
32-031
Country
Poland
Facility Name
CF Centrum Flebologii (#60)
City
Warszawa
State/Province
ul.Witosynskiego 5
ZIP/Postal Code
03-983
Country
Poland
Facility Name
Vestry Close Health Clinic (#8)
City
Luton
State/Province
Bedfordshire
ZIP/Postal Code
LU1 AR
Country
United Kingdom
Facility Name
Chalfont and Gerrards Cross Hospital (#14)
City
Chalfont St Peter
State/Province
Buckinghamshire
ZIP/Postal Code
SL9 9DR
Country
United Kingdom
Facility Name
Wound Healing Research Unit (#1)
City
Heath Park
State/Province
Cardiff
ZIP/Postal Code
CF 14 4XN
Country
United Kingdom
Facility Name
University Hopital (#15)
City
West Midlands
State/Province
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Hainult Health Centre (#24)
City
Chigwell
State/Province
Essex
ZIP/Postal Code
IG7 4DF
Country
United Kingdom
Facility Name
Rayleigh Clinic (#19)
City
Rayleigh
State/Province
Essex
ZIP/Postal Code
SS6 7JP
Country
United Kingdom
Facility Name
Southend University Hopital (#20)
City
Westcliff-on-Sea
State/Province
Essex
ZIP/Postal Code
SSO ORY
Country
United Kingdom
Facility Name
Distric Nurses, The Wilson Practice, Alton Health Centre (#9)
City
Alton
State/Province
Hampshire
ZIP/Postal Code
GU34 2QX
Country
United Kingdom
Facility Name
Fareham College Specialist Leg Care Centre (#13)
City
Fareham
State/Province
Hampshire
ZIP/Postal Code
PO14 1NH
Country
United Kingdom
Facility Name
Southampton Hospital (#6)
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
S016 6YD
Country
United Kingdom
Facility Name
St Mary's Hospital (#7)
City
Armley
State/Province
Leeds
ZIP/Postal Code
LS12 3QE
Country
United Kingdom
Facility Name
Forest Primary Care Center (#18)
City
Edmonton
State/Province
London
ZIP/Postal Code
N9 7HD
Country
United Kingdom
Facility Name
Tissue Viability Service NHS Harrow PCT (#26)
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 4UQ
Country
United Kingdom
Facility Name
Norwich Community Hospital (#21)
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR2 3TU
Country
United Kingdom
Facility Name
Tissue Viability Service, The Willows, Centre for Health Care (#11)
City
Weaste
State/Province
Salford
ZIP/Postal Code
M5 2JR
Country
United Kingdom
Facility Name
Mayday University Hospital Wound Clinic (#10)
City
Thornton Health
State/Province
Surrey
ZIP/Postal Code
CR7 7YE
Country
United Kingdom
Facility Name
Goldsworth Park Health Centre (022)
City
Woking
State/Province
Surrey
ZIP/Postal Code
GU21 3LQ
Country
United Kingdom
Facility Name
Neath Port Talbot Hospital (#17)
City
Port Talbot
State/Province
West Glamorgan
ZIP/Postal Code
SA12 7BX
Country
United Kingdom
Facility Name
City Hospital (#12)
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
University Hospital (#15)
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Cross Street Health Centre (#4)
City
Dudley
State/Province
West Midlands
ZIP/Postal Code
DY1 1RN
Country
United Kingdom
Facility Name
Solihull Hospital (#5)
City
Solihull
State/Province
West Midlands
ZIP/Postal Code
B91 2JL
Country
United Kingdom
Facility Name
Arrowe Park Hospital (#2)
City
Upton
State/Province
Wirral
ZIP/Postal Code
CH49 5PE
Country
United Kingdom
Facility Name
Tissue Viability Consultancy (#3)
City
Eastbourne
ZIP/Postal Code
BN21 4RL
Country
United Kingdom
Facility Name
Royal Free Hospital (#23)
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Stourport Health Centre (#16)
City
Worcestershire
ZIP/Postal Code
DY13 8EH
Country
United Kingdom

12. IPD Sharing Statement

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

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