Venous Leg UlcersPhase 4NCT01036438
Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers
A Phase 4 study testing Mepilex Ag and Mepilex without Ag in people with Venous Leg Ulcers and Mixed Leg Ulcers, run by Molnlycke Health Care AB at 44 sites in 4 countries.
Trial summary
Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcers, Mixed Leg Ulcers
- What is being tested?
- Mepilex Ag and Mepilex without Ag
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 44 sitesin 4 countries
- Study dates
- Dec 2009to Oct 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 with colonised/ local infection in a venous leg ulcer or mixed leg ulcer with an ABPI ≥ 0,8 and < 1.3
- A history of an appropriate compression therapy for at least 2 weeks prior to randomisation
- Subjects with colonised/local infection presenting with three of five following specified signs:
- pain between dressing changes
- exuding wounds
- erythema on peri-wound skin
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- oedema
- odour
- An ulcer size of at least 4 cm2 and a maximum size witch could be covered by one investigational product of 15x15 cm.
- Ulcer duration 6 weeks to 1 year
- In case of multiple ulcers: target ulcer must be at least 3 cm distant from other ulcers.
- Both gender with an age ≥ 18 years
- Signed informed consent
Who cannot join
- > 10% necrotic (black) or fibrinous (yellow) tissue covering the wound bed
- Infected wounds in need of systemic antibiotic treatment
- Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days from inclusion on the wound intended to be included
- Previous treatment with silver product 2 weeks prior to inclusion
- Previous treatment with MepilexAg® on the target ulcer
- Use of systemic antibiotics for any reason during the previous 7 days
Show all 16Show fewer
- Venous surgery 2 weeks prior to inclusion or planned surgery within 8 weeks after inclusion
- Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer/malignancy and severe anaemia) judged by the investigator to be a potential interference in the wound evaluation
- Subjects with poorly controlled diabetes mellitus i.e. HbA1c >8%
- Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent. Subjects inhaling glucocorticosteroids for asthma should not be excluded.
- Known allergy/hypersensitivity to any of the components of the investigation products.
- Subjects with physical and/or mental conditions that are not expected to comply with the investigation due to poor medical condition
- Participation in other clinical investigation(s) within 1 month prior to start of the investigation.
- Previously randomised to this investigation.
- Life expectance of the subject less than 3 months
- Pregnant or breast-feeding women
Trial locations and contacts
44 sites in 4 countries.
44 sites in 4 countries
France23 sites
Polyclinique de Picardie Service d'Angiologie Phlébologie
Amiens, Amiens, 80000
Dermatology Department, University Hospital, Hopital Sud
Amiens, 80054
Hôpital privé d'Antony Service de Dermatologie
Antony, Antony, 92160
Hôpital Saint Jacques - CHU Besançon
Besançon, Besançon, 25030
Résidence le Bristol
Boulogne-sur-Mer, Boulogne-sur-mer, 62200
Service de Dermatologie, Centre Hospitalier Regional Universitaire
Caen, 140 33
CHU Le Bocage Service Dermatologie
Dijon, Dijon Cedex, 21079
Hôpital Albert Michallon Service de médecine vasculaire
Grenoble, Grenoble Cedex 9, 38 043
CHG La Roche-sur-Yon Service de D'Angiologie,Les Oudairies
La Roche-sur-Yon, La Roche-sur-Yon, 85925
Centre Hospitalier le Mans Service de Dermatologie
Le Mans, Le Mans Cedex 9, 72037
Cabinet D'Angeiologie
Lille, 690 00
Hopital Maringer-Villemin- Fournier
Nancy
Pharmacie Centrale-Service Arsenal
Nantes, Nantes, 44093
APHP Hôpital Lariboisère
Paris, Paris, 75010
Hôpital Saint Joseph
Paris, Paris, 75014
Hôpital Rotchild - Jean Rostand
Paris, 75012
Hopital Robert Debré Service de Dermatologie
Reims
Hopital Charles Nicolle
Rouen
Cabinet d'Angiologie, 1 bis rue de Salgareda
Saint-Alban, Saint Alban, 31140
Maison de Santé Protestante de Bordeaux-Bagatelle
Talence
Hopital Beauregard / Secrétariat de Dermatologie
Thionville, 57100
Service de dermatologie
Toulon
Clinique Pasteur
Toulouse, 31076
Czechia11 sites
Fakultní nemocnice U svate Anny, St. Anne´s University Hospital
Brno, 65691
Dermatovenerologická klinika, University Hospital Bohunice,
Brno
Dermatovenerologie Rendlová s.r.o.
České Budějovice, České Budějovice, 37001
Nemocnice Jihlava
Jihlava, Jihlava, 586 01
Krajská nemocnice Liberec
Liberec, Liberec, 46063
Dermatovenerologická klinike, Univerzita Karlova
Pilsen, 305 99
chirugické oddělení, Fakultní nemocnice Královské Vinohrady
Prague, Prague, 10 PSČ 100 34
Fakultní nemocnice Na Bulovce
Prague, 180 00
Nemocnice Podlesí a.s.
Třinec, Třinec, 73961
Uherskohradišťská nemocnice a. s.
Uherské Hradiště, Uherské Hradiště, 68668
Masarykova Hospital, Dermatology dept.
Ústí nad Labem, 401 13
Germany8 sites
Universtätsmedizin Charité Klinik für Dermatologie, Allergologie und Venerologie
Berlin, 10117
Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken -
Bochum, 44805
Universitätsklinikum Hamburg-Eppedorf
Hamburg, 20246
Bramfelder Chaussee 200
Hamburg, 22177
Universität klinikum Jena, Klinik für dermatologie und dermatologische
Jena, 07740
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, Germany, 23538
University Hospital Regensburg
Regensburg
Universitäts-Hautklinik
Tübingen, 72076
Netherlands2 sites
Dermatology department
Amsterdam, 1081
St. Antonius Ziekenhuis
Utrecht
About this study
Official title: A Double-blind, Comparative, Superiority, Multi-centre Investigation Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers
Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction.
- Conditions
- Venous Leg Ulcers, Mixed Leg Ulcers
- Being tested
- Mepilex Ag, Mepilex without Ag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex AgDevice
Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
Mepilex without AgDevice
Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
| Study group | Role | What they receive |
|---|---|---|
| Mepilex product | Placebo comparator | Not described Receives: Device: Mepilex without Ag |
| Mepilex Ag | Active comparator | Not described Receives: Device: Mepilex Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Will be Defined as Absolute Wound Size Reduction.
Efficacy will be defined as absolute wound size reduction.
Measured: 8 weeks
Secondary outcomes (1)
Change in Inflammatory Signs
Change in inflammatory signs
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous Leg UlcersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sylvie Meaume, Dr, Principal investigator, Hopital Rotchild - Jean Rostand, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036438
- Sponsor's protocol ID
- PUMA 416
- Status last verified
- Dec 2013
- First submitted
- 18 Dec 2009
- Last updated
- 12 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Comparative, Superiority, Multi-centre Investigation Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers
- ClinicalTrials.gov ID
- NCT01036438
- Acronym / sponsor ID
- PUMA 416
- Conditions
- Venous Leg Ulcers, Mixed Leg Ulcers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 21 Dec 2009 (estimated)
- Results
- Posted 12 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepilex product | Placebo comparator | Device: Mepilex without Ag |
| Mepilex Ag | Active comparator | Device: Mepilex Ag |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects with colonised/ local infection in a venous leg ulcer or mixed leg ulcer with an ABPI ≥ 0,8 and < 1.3
- A history of an appropriate compression therapy for at least 2 weeks prior to randomisation
- Subjects with colonised/local infection presenting with three of five following specified signs:
- An ulcer size of at least 4 cm2 and a maximum size witch could be covered by one investigational product of 15x15 cm.
- Ulcer duration 6 weeks to 1 year
Key exclusion criteria (16 listed)
- > 10% necrotic (black) or fibrinous (yellow) tissue covering the wound bed
- Infected wounds in need of systemic antibiotic treatment
- Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days from inclusion on the wound intended to be included
- Previous treatment with silver product 2 weeks prior to inclusion
- Previous treatment with MepilexAg® on the target ulcer
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 |
|---|---|---|
| Mepilex AgMepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds. | Device | Mepilex Ag |
| Mepilex without AgMepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds. | Device | Mepilex product |
Primary outcome
Efficacy Will be Defined as Absolute Wound Size Reduction.
Time frame: 8 weeks
Efficacy will be defined as absolute wound size reduction.
1 secondary outcome
Change in Inflammatory Signs
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sylvie Meaume, Dr principal investigator
Hopital Rotchild - Jean Rostand, Paris
44 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mepilex Ag and Mepilex without Ag in people with Venous Leg Ulcers and Mixed Leg Ulcers, run by Molnlycke Health Care AB at 44 sites in 4 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 13 inclusion and 16 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 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in France, Czechia, Germany, Netherlands. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 12 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy Will be Defined as Absolute Wound Size Reduction. (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 12 Sep 2014.