Venous Leg Ulcer (VLU)NCT02167815
A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers
A study testing Mepilex XT in people with Venous Leg Ulcer (VLU), run by Molnlycke Health Care AB at 3 sites in Czechia.
Trial summary
This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the performance of the dressing when used as intended on exuding Venous Leg Ulcers (VLUs) in the inflammatory and granulating stages of the wound… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer (VLU)
- What is being tested?
- Mepilex XT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesCzechia
- Study dates
- May 2014to Jul 2015
- Phase
- Interventional
- 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
- Venous Leg Ulcer
- Exuding wound
- Wound surface covered with sloughy tissue* (before debridement)
- Wound size ≥ 6 cm2
- In case of multiple wounds, target wound must be ≥ 3cm distant from other wounds.
- Wound suitable for treatment with the relevant primary dressing**
Show all 9Show fewer
- Male or female, 18 years of age and above
- Signed Informed Consent
- Sloughy tissue defined as wet, yellow-brown fibrinous tissue present in the wound bed ** Mepilex XT in the intervention group. Standard care in the observation group
Who cannot join
- More than two products of 15 cm x15 cm needed to cover the whole wound and affected peri-wound area
- Wound cavity and/or fistula
- Full thickness burns
- Exposed tendons and/or fascia
- Bleeding wounds
- Malignant or fungating wounds
Show all 12Show fewer
- Wound age > 12 months
- Use of antimicrobial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days from inclusion on the wound intended to be included
- Untreated limb ischemia (according to investigator's judgement) at the time of inclusion
- Subject not suitable for the investigation according to the investigator's judgement
- Subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
- Known allergy/hypersensitivity to any of the components of the primary dressing
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites
Nemocnice Jihlava
Jihlava, Vrchlického, 586 01
The General University Hospital in Prague
Prague
Nemocnice Podlesí a.s.
Třinec, Konská 453, 739 61
About this study
This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the performance of the dressing when used as intended on exuding Venous Leg Ulcers (VLUs) in the inflammatory and granulating stages of the wound healing process.
- Conditions
- Venous Leg Ulcer (VLU)
- Being tested
- Mepilex XT, standard care
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex XTDevice
Experimental arm
standard careOther
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | standard care ( such as alginate, hydrofiber or other treatment) Receives: Other: standard care |
| Intervention ( Mepilex XT) | Experimental | Not described Receives: Device: Mepilex XT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes From Baseline in Condition of the Peri Wound Skin
Deteriorationin of skin condition , Mepilex XT and Standard care (%)
Measured: 16 weeks
Secondary outcomes (3)
Pain Scores on the Visual Analog Scale
Pain at baseline visit, compared with pain at week 16. VAS scale, minimum pain = 0, maximum pain = 100.
Measured: 16 weeks
Users Feedback After Handling or Use as a Measure of Performance.
Investigator/Nurse and Subject evaluation of performance of the primary dressing ( n) Scale= Good , Very Good, Poor, Very Poor
1Ease of application, 2 Ease of removal, 3 Ability to retain exudate, 4 Adherence to healthy skin, 5 Confomability to be repositioned , 6 Overall satisfaction, 7 Dressing sticking to wound bed, 8 Presence of residues on the wound bed. 9 Presence of residues on the healthy skin. 10 Overall evaluation of change in periwound skin condition.
Measured: 16 weeks
Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2015
- Study completionJul 2015
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 Ulcer (VLU)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167815
- Sponsor's protocol ID
- RedEgg 01
- Status last verified
- May 2014
- First submitted
- 15 May 2014
- Last updated
- 26 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT02167815
- Acronym / sponsor ID
- RedEgg 01
- Conditions
- Venous Leg Ulcer (VLU)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Posted 26 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the performance of the dressing when used as intended on exuding Venous Leg Ulcers (VLUs) in the inflammatory and granulating stages of the wound healing process.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Other: standard carestandard care ( such as alginate, hydrofiber or other treatment) |
| Intervention ( Mepilex XT) | Experimental | Device: Mepilex XT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Venous Leg Ulcer
- Exuding wound
- Wound surface covered with sloughy tissue* (before debridement)
- Wound size ≥ 6 cm2
- In case of multiple wounds, target wound must be ≥ 3cm distant from other wounds.
Key exclusion criteria (12 listed)
- More than two products of 15 cm x15 cm needed to cover the whole wound and affected peri-wound area
- Wound cavity and/or fistula
- Full thickness burns
- Exposed tendons and/or fascia
- Bleeding wounds
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 XTExperimental arm | Device | Intervention ( Mepilex XT) |
| standard care | Other | Standard care |
Primary outcome
Changes From Baseline in Condition of the Peri Wound Skin
Time frame: 16 weeks
Deteriorationin of skin condition , Mepilex XT and Standard care (%)
3 secondary outcomes
Pain Scores on the Visual Analog Scale
Time frame: 16 weeks
Users Feedback After Handling or Use as a Measure of Performance.
Time frame: 16 weeks
Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations.
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Venous Leg Ulcer (VLU)
Not yet recruitingPhase 2
Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU)
Venus Leg Ulcers
RecruitingPhase 3
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
Venous Leg Ulcer (VLU)
Not yet recruitingPhase 1/2
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
Lower Extremity, Chronic Ulcers
Recruiting
Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
Diabetic Foot Ulcer, Foot Ulcer Chronic
Recruiting
Effect of Photobiomodulation on Healing of Venous Leg Ulcers
Venous Leg Ulcer (VLU), Venous Hypertension Ulcers
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepilex XT in people with Venous Leg Ulcer (VLU), run by Molnlycke Health Care AB at 3 sites in Czechia.
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 9 inclusion and 12 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2016). 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?
Changes From Baseline in Condition of the Peri Wound Skin (time frame: 16 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 26 Oct 2016.