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

NCT01084577 | Completed Phase 4

• 1 other identifier: CW-0142-09-U354
• Study Type: interventional
• Target: 266
• Locations: 5 countries
• Sites: 56

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.

Conditions

Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Wound area reduction from baseline (relative)

  8 weeks

Secondary Outcomes (3)

• Wound closure

  8 weeks

• Clinical evolution of the wound

  8 weeks

• Tolerance

  8 weeks

Study Arms (2)

Urgotul® Silver

ACTIVE COMPARATOR

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

Device: Urgotul® Silver

AQUACEL® Ag

ACTIVE COMPARATOR

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

Device: AQUACEL® Ag

Interventions

AQUACEL® Ag DEVICE

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

AQUACEL® Ag

Urgotul® Silver DEVICE

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

Urgotul® Silver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects with a history of skin sensitivity to any of the components of the study product.
• 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).

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Sites (56)

Arhus Universitets Hospital (#47)

Aarhus, 8000, Denmark

Location

Bispebjerg Universitets Hospital (#45)

Copenhagen, 2400, Denmark

Location

Odense Universitets Hospital (#46)

Odense, 5000, Denmark

Location

(#35)

Paris, Neuilly Sur Siene, 92200, France

Location

37 Bd Bury (#42)

Angoulême, 16 000, France

Location

CH de La Fere, (#44)

La Fère, 02800, France

Location

Clinique des Augustines (#38)

Malestroit, BP 23 56140, France

Location

19 rue des Clers (#37)

Metz, 57000, France

Location

Hopital Brocca, 54/56 rue Pascal (#41)

Paris, 75013, France

Location

Centre de Sante (#36)

Paris, 75019, France

Location

Clinique Pasteur (#40)

Toulouse, 31 000, France

Location

Praxis Dr Thinesse-Mallwitz (#31)

München, Faustlestr 3, 80339, Germany

Location

Hautarztpraxis Dr Klovekorn (#33)

Gilching, Romerstr 4, 82205, Germany

Location

Chirurgisches Zentrum Bethanien (#34)

Frankfurt am Main, Usinger Str 5, 60389, Germany

Location

Arztin fur Allgemeinmedizin (#30)

München, 81667, Germany

Location

Poradnia Medycyny Paliatywnej, Hospicjum Palium, SK im. Przemienienia Panskiego nr.1(#49)

Poznan, Os. Rusa 25a, 61-240, Poland

Location

NZoZ SEP-MED (#59)

Warsaw, Ul. Hoza 19, 00-521, Poland

Location

Centr. Med. Beluga-Med, NZOZ (#53)

Krakow, Ul. Obopolna 4a, 30-069, Poland

Location

Poradnia Chorob MIKOMED (#55)

Lodz, Ul. Plugowa 51/53, 94-236, Poland

Location

NZOZ Por. Chrurgiczna (#52)

Strzelce Opolskie, Ul. Powstancow Slaskich 9, 47-100, Poland

Location

Centr. Diagnostyki Ginek.-Poloz. (#51)

Opole, Ul.1-go Maja 9/69-73, 45-068, Poland

Location

Szpital Woj.w Bielsku-Bialej (#61)

Bielsko-Biala, ul.Armii Krajowej 101, 43-316, Poland

Location

Poradnia Chirurgiczna Szpital, Specjalistyczny nr.2 (#50)

Bytom, ul.Batorego 15, 41-902, Poland

Location

Nzoz Certus (#64)

Lodz, ul.Kopernika 67-69, 90-553, Poland

Location

Venavita (#63)

Poznan, ul.Kurpiowska 8/5, 60-602, Poland

Location

Specjal.Pomoc Med.MEDSERVICE (#56)

Zabrze, ul.M.Sklodowskiej-Curie 34, 41-800, Poland

Location

SPZOZ nr.1 Przyszpitalna Por. (#58)

Rzeszów, ul.Rycerska 4, 35-241, Poland

Location

Nzoz Serce Sercu (#62)

Mogilany, ul.Sw.Bartlomieja Apostola 21, 32-031, Poland

Location

CF Centrum Flebologii (#60)

Warsaw, ul.Witosynskiego 5, 03-983, Poland

Location

SPZOZ UM w Lodzi (#54)

Ul. Narutowicza 96, Łódź Voivodeship, 90-151, Poland

Location

Vestry Close Health Clinic (#8)

Luton, Bedfordshire, LU1 AR, United Kingdom

Location

Chalfont and Gerrards Cross Hospital (#14)

Chalfont Saint Peter, Buckinghamshire, SL9 9DR, United Kingdom

Location

Wound Healing Research Unit (#1)

Heathpark, Cardiff, CF 14 4XN, United Kingdom

Location

University Hopital (#15)

West Midlands, Coventry, CV2 2DX, United Kingdom

Location

Hainult Health Centre (#24)

Chigwell, Essex, IG7 4DF, United Kingdom

Location

Rayleigh Clinic (#19)

Rayleigh, Essex, SS6 7JP, United Kingdom

Location

Southend University Hopital (#20)

Westcliff-on-Sea, Essex, SSO ORY, United Kingdom

Location

Distric Nurses, The Wilson Practice, Alton Health Centre (#9)

Alton, Hampshire, GU34 2QX, United Kingdom

Location

Fareham College Specialist Leg Care Centre (#13)

Fareham, Hampshire, PO14 1NH, United Kingdom

Location

Southampton Hospital (#6)

Southampton, Hampshire, S016 6YD, United Kingdom

Location

St Mary's Hospital (#7)

Armley, Leeds, LS12 3QE, United Kingdom

Location

Forest Primary Care Center (#18)

Edmonton, London, N9 7HD, United Kingdom

Location

Tissue Viability Service NHS Harrow PCT (#26)

Harrow, Middlesex, HA1 4UQ, United Kingdom

Location

Norwich Community Hospital (#21)

Norwich, Norfolk, NR2 3TU, United Kingdom

Location

Tissue Viability Service, The Willows, Centre for Health Care (#11)

Weaste, Salford, M5 2JR, United Kingdom

Location

Mayday University Hospital Wound Clinic (#10)

Thornton Health, Surrey, CR7 7YE, United Kingdom

Location

Goldsworth Park Health Centre (022)

Woking, Surrey, GU21 3LQ, United Kingdom

Location

Neath Port Talbot Hospital (#17)

Port Talbot, West Glamorgan, SA12 7BX, United Kingdom

Location

City Hospital (#12)

Birmingham, West Midlands, B18 7QH, United Kingdom

Location

University Hospital (#15)

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

Cross Street Health Centre (#4)

Dudley, West Midlands, DY1 1RN, United Kingdom

Location

Solihull Hospital (#5)

Solihull, West Midlands, B91 2JL, United Kingdom

Location

Arrowe Park Hospital (#2)

Upton, Wirral, CH49 5PE, United Kingdom

Location

Tissue Viability Consultancy (#3)

Eastbourne, BN21 4RL, United Kingdom

Location

Royal Free Hospital (#23)

London, NW3 2QG, United Kingdom

Location

Stourport Health Centre (#16)

Worcestershire, DY13 8EH, United Kingdom

Location

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dheerendra Kommala, MD

  ConvaTec Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 10, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 21, 2011

Record last verified: 2011-02

Locations

FR (8); PL (15); GB (26); DE (4); DK (3)