Leg UlcerPhase 4NCT01084577
AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers
A Phase 4 study testing AQUACEL® Ag and Urgotul® Silver in people with Leg Ulcer, run by ConvaTec Inc. at 56 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcer
- What is being tested?
- AQUACEL® Ag and Urgotul® Silver
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 56 sitesin 5 countries
- Study dates
- Jan 2010to Jan 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
56 sites in 5 countries.
56 sites in 5 countries
United Kingdom26 sites
Distric Nurses, The Wilson Practice, Alton Health Centre (#9)
Alton, Hampshire, GU34 2QX
St Mary's Hospital (#7)
Armley, Leeds, LS12 3QE
City Hospital (#12)
Birmingham, West Midlands, B18 7QH
Chalfont and Gerrards Cross Hospital (#14)
Chalfont Saint Peter, Buckinghamshire, SL9 9DR
Hainult Health Centre (#24)
Chigwell, Essex, IG7 4DF
University Hospital (#15)
Coventry, West Midlands, CV2 2DX
Cross Street Health Centre (#4)
Dudley, West Midlands, DY1 1RN
Tissue Viability Consultancy (#3)
Eastbourne, BN21 4RL
Forest Primary Care Center (#18)
Edmonton, London, N9 7HD
Fareham College Specialist Leg Care Centre (#13)
Fareham, Hampshire, PO14 1NH
Tissue Viability Service NHS Harrow PCT (#26)
Harrow, Middlesex, HA1 4UQ
Wound Healing Research Unit (#1)
Heathpark, Cardiff, CF 14 4XN
Royal Free Hospital (#23)
London, NW3 2QG
Vestry Close Health Clinic (#8)
Luton, Bedfordshire, LU1 AR
Norwich Community Hospital (#21)
Norwich, Norfolk, NR2 3TU
Neath Port Talbot Hospital (#17)
Port Talbot, West Glamorgan, SA12 7BX
Rayleigh Clinic (#19)
Rayleigh, Essex, SS6 7JP
Solihull Hospital (#5)
Solihull, West Midlands, B91 2JL
Southampton Hospital (#6)
Southampton, Hampshire, S016 6YD
Mayday University Hospital Wound Clinic (#10)
Thornton Health, Surrey, CR7 7YE
Arrowe Park Hospital (#2)
Upton, Wirral, CH49 5PE
Tissue Viability Service, The Willows, Centre for Health Care (#11)
Weaste, Salford, M5 2JR
University Hopital (#15)
West Midlands, Coventry, CV2 2DX
Southend University Hopital (#20)
Westcliff-on-Sea, Essex, SSO ORY
Goldsworth Park Health Centre (022)
Woking, Surrey, GU21 3LQ
Stourport Health Centre (#16)
Worcestershire, DY13 8EH
Poland15 sites
Szpital Woj.w Bielsku-Bialej (#61)
Bielsko-Biala, ul.Armii Krajowej 101, 43-316
Poradnia Chirurgiczna Szpital, Specjalistyczny nr.2 (#50)
Bytom, ul.Batorego 15, 41-902
Centr. Med. Beluga-Med, NZOZ (#53)
Krakow, Ul. Obopolna 4a, 30-069
Poradnia Chorob MIKOMED (#55)
Lodz, Ul. Plugowa 51/53, 94-236
Nzoz Certus (#64)
Lodz, ul.Kopernika 67-69, 90-553
Nzoz Serce Sercu (#62)
Mogilany, ul.Sw.Bartlomieja Apostola 21, 32-031
Centr. Diagnostyki Ginek.-Poloz. (#51)
Opole, Ul.1-go Maja 9/69-73, 45-068
Poradnia Medycyny Paliatywnej, Hospicjum Palium, SK im. Przemienienia Panskiego nr.1(#49)
Poznan, Os. Rusa 25a, 61-240
Venavita (#63)
Poznan, ul.Kurpiowska 8/5, 60-602
SPZOZ nr.1 Przyszpitalna Por. (#58)
Rzeszów, ul.Rycerska 4, 35-241
NZOZ Por. Chrurgiczna (#52)
Strzelce Opolskie, Ul. Powstancow Slaskich 9, 47-100
SPZOZ UM w Lodzi (#54)
Ul. Narutowicza 96, Łódź Voivodeship, 90-151
NZoZ SEP-MED (#59)
Warsaw, Ul. Hoza 19, 00-521
CF Centrum Flebologii (#60)
Warsaw, ul.Witosynskiego 5, 03-983
Specjal.Pomoc Med.MEDSERVICE (#56)
Zabrze, ul.M.Sklodowskiej-Curie 34, 41-800
France8 sites
37 Bd Bury (#42)
Angoulême, 16 000
CH de La Fere, (#44)
La Fère, 02800
Clinique des Augustines (#38)
Malestroit, BP 23 56140
19 rue des Clers (#37)
Metz, 57000
(#35)
Paris, Neuilly Sur Siene, 92200
Hopital Brocca, 54/56 rue Pascal (#41)
Paris, 75013
Centre de Sante (#36)
Paris, 75019
Clinique Pasteur (#40)
Toulouse, 31 000
Germany4 sites
Chirurgisches Zentrum Bethanien (#34)
Frankfurt am Main, Usinger Str 5, 60389
Hautarztpraxis Dr Klovekorn (#33)
Gilching, Romerstr 4, 82205
Praxis Dr Thinesse-Mallwitz (#31)
München, Faustlestr 3, 80339
Arztin fur Allgemeinmedizin (#30)
München, 81667
Denmark3 sites
Arhus Universitets Hospital (#47)
Aarhus, 8000
Bispebjerg Universitets Hospital (#45)
Copenhagen, 2400
Odense Universitets Hospital (#46)
Odense, 5000
About this study
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
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
- Being tested
- AQUACEL® Ag, Urgotul® Silver
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQUACEL® AgDevice
AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
Urgotul® SilverDevice
Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Urgotul® Silver | Active comparator | Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks. Receives: Device: Urgotul® Silver |
| AQUACEL® Ag | Active comparator | AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks. Receives: Device: AQUACEL® Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound area reduction from baseline (relative)
Measured: 8 weeks
Secondary outcomes (3)
Wound closure
Measured: 8 weeks
Clinical evolution of the wound
presence of each of the 5 selected clinical signs
Measured: 8 weeks
Tolerance
occurrence of local adverse events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dheerendra Kommala, MD, Study director, ConvaTec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084577
- Sponsor's protocol ID
- CW-0142-09-U354
- Status last verified
- Feb 2011
- First submitted
- 9 Mar 2010
- Last updated
- 21 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01084577
- Acronym / sponsor ID
- CW-0142-09-U354
- Conditions
- Leg Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urgotul® Silver | Active comparator | Device: Urgotul® SilverUrgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks. |
| AQUACEL® Ag | Active comparator | Device: AQUACEL® AgAQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AQUACEL® AgAQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks. | Device | AQUACEL® Ag |
| Urgotul® SilverUrgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks. | Device | Urgotul® Silver |
Primary outcome
Wound area reduction from baseline (relative)
Time frame: 8 weeks
3 secondary outcomes
Wound closure
Time frame: 8 weeks
Clinical evolution of the wound
Time frame: 8 weeks
Tolerance
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
Related trials for Leg Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dheerendra Kommala, MD study director
ConvaTec Inc.
56 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AQUACEL® Ag and Urgotul® Silver in people with Leg Ulcer, run by ConvaTec Inc. at 56 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United Kingdom, Poland, France, Germany, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound area reduction from baseline (relative) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2011.