Wound HealExuFlex01NCT04960553
A PMCF Investigation on Exuding Chronic Wounds Using Exufiber® as Primary Dressing, and Mepilex® Border Flex/Comfort
A study testing Exufiber® and Mepilex® Border Flex in people with Wound Heal, run by Molnlycke Health Care AB at 7 sites in 3 countries.
Trial summary
The overall objective of this post market clinical follow-up (PMCF) investigation is to follow the progress of exuding chronic wounds to healing, or up to 12 weeks, whichever occurs first, consecutively using Exufiber® as primary dressing, and Mepilex® Border Flex (Mepilex Border Comfort) as primary dressing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal
- What is being tested?
- Exufiber® and Mepilex® Border Flex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 7 Dec 2021to 20 Jan 2023
- Phase
- Interventional
- 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
- Provision of informed consent
- Both genders ≥18 years old.
- Exuding pressure ulcer, exuding diabetic foot ulcer or exuding venous leg ulcer (an exuding wound defined as one that requires highly absorbent dressing - as per clinical judgement)
- Chronic wound at least 4 weeks duration (chronic would be defined after 4 weeks).
- ABPI (within the last 3 months) ≥0.7 for both legs (if both present). If ABPI >1.4, then big toe pressure >60mmHg is required or an alternative measurement verifying normal distal arterial flow.
- At entry into the study, the ulcer or wound area should be 0.8 cm² - 70 cm².
Who cannot join
- Known allergy/hypersensitivity to the dressing or its components.
- Subject included in other ongoing clinical investigation at present or during the past 30 days
- Pregnancy or lactation at time of study participation.
- Target wound DFU <0.8 cm² , VLU <3 cm² , PU <1 cm² , post debridement (measured as greatest length x greatest width)
- Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at recruitment.
- Other wounds within 3 cm from target wound
- Subject not suitable for the investigation according to the investigator's judgement.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United Kingdom3 sites
Northumbria Healthcare NHS Foundation Trust
Ashington
Manchester University NHS Foundation Trust
Manchester
Salford Royal NHS Foundation Trust
Salford
Portugal2 sites
Unidade de Cuidados Continuados Ordem da Trindade
Porto
Unidade Cuidados Continuados - Mutivaze - WeCare
Póvoa de Varzim
About this study
Official title: Prospective, Open, Non-comparative, Multi-centre, Post Market Clinical Follow-up Investigation to Follow the Progress of Exuding Chronic Wounds to Healing Using Exufiber® as Primary Dressing, and Mepilex® Border Flex/Comfort
The overall objective of this post market clinical follow-up (PMCF) investigation is to follow the progress of exuding chronic wounds to healing, or up to 12 weeks, whichever occurs first, consecutively using Exufiber® as primary dressing, and Mepilex® Border Flex (Mepilex Border Comfort) as primary dressing.
Read the detailed description
This investigation is as a prospective, open, non-comparative, multi-centre investigation with the aim to follow exuding chronic wound progression. The investigation will include subjects from three populations suffering from exuding chronic wounds (Venous Leg Ulcers, Diabetic Foot Ulcers and Pressure Ulcers). The target wound for all subjects will initially be treated with Exufiber® as primary dressing. As the wound progress and wound exudate production is reduced, the Exufiber will be replaced by the Mepilex Border Flex dressing. For ulcers located at sacrum or heel, the Mepilex Border Heel or Mepilex Border Sacrum will be used.
- Conditions
- Wound Heal
- Being tested
- Exufiber® and Mepilex® Border Flex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exufiber® and Mepilex® Border FlexDevice
Post Market Clinical Follow-up Investigation applying Exufiber® and Mepilex® Border Flex to 102 subjects who meet the study criteria for up to 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Device : Post Market Clinical Follow-up Investigation applying Exufiber® and Mepilex® Border Flex | Experimental | Post Market Clinical Follow-up investigation : Up to 102 subjects with exuding chronic wounds deemed adequate by the Principle Investigator and Clinical Team for assigned treatment Receives: Device: Exufiber® and Mepilex® Border Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound progress measured by investigator evaluation
Wound progress of exuding chronic wounds from baseline to last visit where Exufiber is applicable, up to 12 weeks.
Measured: Up to 12 weeks
Secondary outcomes (9)
Wound progress measured by investigator evaluation
Wound progress of exuding chronic wounds from baseline to final visit and from first visit where Mepilex Border Flex is applicable as primary dressing to final visit.
Measured: Up to 12 weeks
Absolute and percentage change in wound area of exuding chronic wounds captured by an independent evaluator evaluating wound photos through the software program PictZar® Digital Planimetry
Absolute and percentage change in wound area of exuding chronic wounds, from baseline to last visit where Exufiber is applicable and to final visit; and from first visit where Mepilex Border Flex is applicable as primary dressing to final visit.
Measured: Up to 12 weeks
Change in necrotic/sloughy tissue of exuding chronic wounds captured through visual judgement by investigator/designee through a scale in percentage
Change in necrotic/sloughy tissue of exuding chronic wounds from baseline to last visit where Exufiber is applicable and to final visit; and from first visit where Mepilex Border Flex is applicable as primary dressing to final visit.
Measured: Up to 12 weeks
Change in granulation tissue of exuding chronic wounds captured through visual judgement by investigator/designee through a scale in percentage
Assessment of exuding wound from baseline to last visit where Exufiber is applicable and to final visit; and from first visit where Mepilex Border Flex is applicable as primary dressing to final visit.
Measured: Up to12 weeks
Changes in peri-wound skin condition of exuding chronic wounds
Changes in peri-wound skin condition of exuding chronic wounds from baseline to last visit where Exufiber is applicable and to final visit; and from first visit where Mepilex Border Flex is applicable as primary dressing to final visit.
Measured: Up to12 weeks
Device usability, wound fluid retention and dressing properties
Investigator's evaluation of the wound status and the Exufiber and Mepilex Border Flex dressings, including usability, wound fluid retention and dressing properties.
Measured: Up to 12 weeks
Subject's perception of pain and comfort
Subject's perception of Pain and Pain intensity with a numerical rating scale (NRS) range 0-10 cm where 0 is no pain and 10 pain as intense you can imagine. Comfort during Exufiber and Mepilex Border Flex dressings application, removal and use evaluated through questions asked by the investigator/designee to the subject with a range from very poor to very good.
Measured: Up to12 weeks
Dressing wear time
Dressing wear time of the Exufiber dressing and the Mepilex Border Flex dressing, and supporting techniques applied.
Measured: Up to12 weeks
Cost-effectiveness
Cost-effectiveness; wound care consumables and frequency of dressings changes.
Measured: Up to12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start7 Dec 2021
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Why it stopped: The study was early terminated because new data related to the investigational device were available making this investigation no longer scientifically relevant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT04960553
- Sponsor's protocol ID
- PD-708370
- Acronym
- ExuFlex01
- Status last verified
- Feb 2023
- First submitted
- 21 Jun 2021
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open, Non-comparative, Multi-centre, Post Market Clinical Follow-up Investigation to Follow the Progress of Exuding Chronic Wounds to Healing Using Exufiber® as Primary Dressing, and Mepilex® Border Flex/Comfort
- ClinicalTrials.gov ID
- NCT04960553
- Acronym / sponsor ID
- ExuFlex01 / PD-708370
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was early terminated because new data related to the investigational device were available making this investigation no longer scientifically relevant
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 14 Jul 2021 (actual)
- 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.
The overall objective of this post market clinical follow-up (PMCF) investigation is to follow the progress of exuding chronic wounds to healing, or up to 12 weeks, whichever occurs first, consecutively using Exufiber® as primary dressing, and Mepilex® Border Flex (Mepilex Border Comfort) as primary dressing.
Detailed description
This investigation is as a prospective, open, non-comparative, multi-centre investigation with the aim to follow exuding chronic wound progression. The investigation will include subjects from three populations suffering from exuding chronic wounds (Venous Leg Ulcers, Diabetic Foot Ulcers and Pressure Ulcers). The target wound for all subjects will initially be treated with Exufiber® as primary dressing. As the wound progress and wound exudate production is reduced, the Exufiber will be replaced by the Mepilex Border Flex dressing. For ulcers located at sacrum or heel, the Mepilex Border Heel or Mepilex Border Sacrum will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device : Post Market Clinical Follow-up Investigation applying Exufiber® and Mepilex® Border Flex | Experimental | Device: Exufiber® and Mepilex® Border FlexPost Market Clinical Follow-up investigation : Up to 102 subjects with exuding chronic wounds deemed adequate by the Principle Investigator and Clinical Team for assigned treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of informed consent
- Both genders ≥18 years old.
- Exuding pressure ulcer, exuding diabetic foot ulcer or exuding venous leg ulcer (an exuding wound defined as one that requires highly absorbent dressing - as per clinical judgement)
- Chronic wound at least 4 weeks duration (chronic would be defined after 4 weeks).
- ABPI (within the last 3 months) ≥0.7 for both legs (if both present). If ABPI >1.4, then big toe pressure >60mmHg is required or an alternative measurement verifying normal distal arterial flow.
Key exclusion criteria (7 listed)
- Known allergy/hypersensitivity to the dressing or its components.
- Subject included in other ongoing clinical investigation at present or during the past 30 days
- Pregnancy or lactation at time of study participation.
- Target wound DFU <0.8 cm² , VLU <3 cm² , PU <1 cm² , post debridement (measured as greatest length x greatest width)
- Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at recruitment.
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 |
|---|---|---|
| Exufiber® and Mepilex® Border FlexPost Market Clinical Follow-up Investigation applying Exufiber® and Mepilex® Border Flex to 102 subjects who meet the study criteria for up to 12 weeks | Device | Device : Post Market Clinical Follow-up Investigation applying Exufiber® and Mepilex® Border Flex |
Primary outcome
Wound progress measured by investigator evaluation
Time frame: Up to 12 weeks
Wound progress of exuding chronic wounds from baseline to last visit where Exufiber is applicable, up to 12 weeks.
9 secondary outcomes
Wound progress measured by investigator evaluation
Time frame: Up to 12 weeks
Absolute and percentage change in wound area of exuding chronic wounds captured by an independent evaluator evaluating wound photos through the software program PictZar® Digital Planimetry
Time frame: Up to 12 weeks
Change in necrotic/sloughy tissue of exuding chronic wounds captured through visual judgement by investigator/designee through a scale in percentage
Time frame: Up to 12 weeks
Change in granulation tissue of exuding chronic wounds captured through visual judgement by investigator/designee through a scale in percentage
Time frame: Up to12 weeks
Changes in peri-wound skin condition of exuding chronic wounds
Time frame: Up to12 weeks
Device usability, wound fluid retention and dressing properties
Time frame: Up to 12 weeks
Subject's perception of pain and comfort
Time frame: Up to12 weeks
Dressing wear time
Time frame: Up to12 weeks
Cost-effectiveness
Time frame: Up to12 weeks
Results and safety
The study was stopped early (reason given: The study was early terminated because new data related to the investigational device were available making this investigation no longer scientifically relevant). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exufiber® and Mepilex® Border Flex in people with Wound Heal, run by Molnlycke Health Care AB at 7 sites in 3 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, Belgium, Portugal. 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?
The study was stopped early (reason given: The study was early terminated because new data related to the investigational device were available making this investigation no longer scientifically relevant). Results are not available in the source record.
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 progress measured by investigator evaluation (time frame: Up to 12 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 22 Feb 2023.