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

September 11, 2014 updated by: Molnlycke Health Care AB

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
201

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 65691
        • Fakultní nemocnice U svate Anny, St. Anne´s University Hospital
      • Brno, Czech Republic
        • Dermatovenerologická klinika, University Hospital Bohunice,
      • Jihlava, Czech Republic, 586 01
        • Nemocnice Jihlava
      • Liberec, Czech Republic, 46063
        • Krajska Nemocnice Liberec
      • Plzen, Czech Republic, 305 99
        • Dermatovenerologická klinike, Univerzita Karlova
      • Prague, Czech Republic, 180 00
        • Fakultni nemocnice Na Bulovce
      • Praha, Czech Republic, 10 PSČ 100 34
        • chirugické oddělení, Fakultní nemocnice Královské Vinohrady
      • Třinec, Czech Republic, 73961
        • Nemocnice Podlesí a.s.
      • Uherské Hradiště, Czech Republic, 68668
        • Uherskohradišťská nemocnice a. s.
      • Usti nad Labem, Czech Republic, 401 13
        • Masarykova Hospital, Dermatology dept.
      • České Budějovice, Czech Republic, 37001
        • Dermatovenerologie Rendlová s.r.o.
  • France
      • Amiens, France, 80000
        • Polyclinique de Picardie Service d'Angiologie Phlébologie
      • Amiens cedex, France, 80054
        • Dermatology Department, University Hospital, Hopital Sud
      • Antony, France, 92160
        • Hôpital privé d'Antony Service de Dermatologie
      • Besançon, France, 25030
        • Hôpital Saint Jacques - CHU Besançon
      • Boulogne-sur-mer, France, 62200
        • Résidence le Bristol
      • Caen cedex 9, France, 140 33
        • Service de Dermatologie, Centre Hospitalier Regional Universitaire
      • Dijon Cedex, France, 21079
        • CHU Le Bocage Service Dermatologie
      • Grenoble Cedex 9, France, 38 043
        • Hôpital Albert Michallon Service de médecine vasculaire
      • La Roche-sur-Yon, France, 85925
        • CHG La Roche-sur-Yon Service de D'Angiologie,Les Oudairies
      • Le Mans cedex 9, France, 72037
        • Centre Hospitalier le Mans Service de Dermatologie
      • Lille, France, 690 00
        • Cabinet D'Angeiologie
      • Nancy, France
        • Hopital Maringer-Villemin- Fournier
      • Nantes, France, 44093
        • Pharmacie Centrale-Service Arsenal
      • Paris, France, 75014
        • Hôpital Saint Joseph
      • Paris, France, 75010
        • APHP Hôpital Lariboisère
      • Paris, France, 75012
        • Hôpital Rotchild - Jean Rostand
      • Reims, France
        • Hopital Robert Debré Service de Dermatologie
      • Rouen cedex, France
        • Hôpital Charles Nicolle
      • St Alban, France, 31140
        • Cabinet d'Angiologie, 1 bis rue de Salgareda
      • Talence Cedex, France
        • Maison de Santé Protestante de Bordeaux-Bagatelle
      • Thionville, France, 57100
        • Hopital Beauregard / Secrétariat de Dermatologie
      • Toulon cedex, France
        • Service de dermatologie
      • Toulouse, France, 31076
        • Clinique Pasteur
  • Germany
      • Berlin, Germany, 10117
        • Universtätsmedizin Charité Klinik für Dermatologie, Allergologie und Venerologie
      • Bochum, Germany, 44805
        • Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken -
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppedorf
      • Hamburg, Germany, 22177
        • Bramfelder Chaussee 200
      • Jena, Germany, 07740
        • Universität klinikum Jena, Klinik für dermatologie und dermatologische
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein Campus Lübeck
      • Regensburg, Germany
        • University Hospital Regensburg
      • Tübingen, Germany, 72076
        • Universitäts-Hautklinik
  • Netherlands
      • Amsterdam, Netherlands, 1081
        • Dermatology department
      • Utrecht, Netherlands
        • St. Antonius Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
    • 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

Exclusion Criteria:

  • > 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Mepilex product
Device: Mepilex without Ag
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.
ACTIVE_COMPARATOR: Mepilex Ag
Device: Mepilex Ag
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy Will be Defined as Absolute Wound Size Reduction.
Time Frame: 8 weeks
Efficacy will be defined as absolute wound size reduction.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Inflammatory Signs
Time Frame: 4 weeks
Change in inflammatory signs
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Molnlycke Health Care AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sylvie Meaume, Dr, Hopital Rotchild - Jean Rostand, Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PUMA 416

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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