Venous Leg UlcerPD-497314NCT02921750
Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin
A study testing Exufiber Gelling Fibre Dressing and Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre in people with Venous Leg Ulcer, run by Molnlycke Health Care AB at 33 sites in 6 countries.
Trial summary
The investigation is designed as an open, randomized, non-inferiority, multi-centre investigation. 212 evaluable subjects will be randomised. Subjects to be included will suffer from an exuding venous or mixed ulcer of predominantly venous origin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Exufiber Gelling Fibre Dressing and Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 33 sitesin 6 countries
- Study dates
- Oct 2016to 27 Nov 2019
- 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
- Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form
- Both gender ≥18 years old
- Ulcer moderately or strongly exudative justifying the use of an absorbent dressing
- (History of compression at least two weeks before inclusion) Deleted in Am.2
- (Wound covered with slough ≥70%) Deleted in Am.4
- 0.7≤ABPI<1.3
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- Ulcer duration 6 weeks to 60 months
- Ulcer size 3 cm2-100 cm2
- Target ulcer at least 3 cm away from any other lesion
Who cannot join
- Known allergy/hypersensitivity to the dressings
- Pregnant or breastfeeding
- Circumferential wounds (the entire wound should be able to be captured on a single image/photo)
- Subjects who will have problems following the protocol
- Subjects included in other ongoing clinical investigation evaluating wound dressings at present or during the past 30 days
- Patient with a systemic infection not controlled by suitable antibiotic treatment
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- Clinically infected wound according to the judgement of the investigator (heat, pain, swelling, redness or purulent secretion)
- Wound covered with black necrosis
- Dry wounds
- Malignant wound degeneration
- Current treatment with radiotherapy, chemotherapy, immunosuppressant drugs or high doses of oral corticosteroids if any
- Subject with deep vein thrombosis within 3 months prior to inclusion
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
Germany10 sites
Wundzentrum Augsburg
Augsburg, 86152
WundZentrum Dortmund
Dortmund, 44137
WundZentrum Düsseldorf
Düsseldorf
Universitätsklinikum Erlangen
Erlangen, 91054
Venenzentrum Freiburg
Freiburg im Breisgau, 79008
Paracelsus-Klinik am Silbersee
Hanover
University Hospital Schleswig-Holstein
Kiel, 24105
Johannes-Gutenberg-Universität Mainz
Mainz, 55131
WundZentrum München Nord
München, 80939
WundZentrum Ulm
Ulm, 89077
Czechia7 sites
St. Ann University Hospital Dep of Dermatovenereology
Brno, 656 91
Hospital Jihlava
Jihlava, 58601
Regional hospital Pardubice Dermatology Department
Pardubice, 53203
Fakultní nemocnice Královské Vinohrady (FNKV)Department of General Surgery 3
Prague, 10034
General University Hospital in Prague
Prague, 128 08
Diabetologie
Soběslav, 39201
Salvatella LTD
Třinec, 739 61
France6 sites
Hôpital Michallon
Grenoble, 38043
Groupe Hospitalier
La Rochelle, 17019
Hospital Géneral du Mans
Le Mans, 72000
Clinique du Parc Unité de Cicatrisation
Lyon, 69006
CHU Nantes
Nantes, 44000
Clinique Pasteur
Toulouse, 31076
Sweden5 sites
Lund university Hospital,
Lund, 22185
Avdelningen för kliniska prövningar, Universitetssjukhuset Örebro
Örebro, 70185
Skellefteå Lasarett
Skellefteå, 931 41
Karolinska Trial Alliance, Prim
Stockholm, 113 61
Södersjukhuset (Sårcentrum)
Stockholm, 118 83
Poland4 sites
Usługi Medyczne PRO-MED Sp. z o.o., ul.
Gliwice, 44-109
Niepubliczny Zakład Opieki Zdrowotnej "GAM-MED", ul.
Kielce, 25-315
Niepubliczny Zakład Opieki Zdrowotnej "Mikomed", ul.
Lodz, 94-238
Medical Hair & Esthetic, ul.
Lublin, 20-844
About this study
Official title: A Randomised Multi-centre Non-inferiority Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin
The investigation is designed as an open, randomized, non-inferiority, multi-centre investigation.
212 evaluable subjects will be randomised. Subjects to be included will suffer from an exuding venous or mixed ulcer of predominantly venous origin. Subjects will either be randomized to Exufiber®Gelling Fibre Dressing or Aquacel®Extra Hydrofiber® Dressing with Strengthening Fibre using, centralized randomization
Read the detailed description
Visits are planned for baseline followed by 1, 2, 3, 4 and 6 weeks post treatment. The sub-group of at least 50 subjects will also be followed at week 8, 12, 16, 20, and 24 post treatment or until wound is healed if earlier.
- Conditions
- Venous Leg Ulcer
- Being tested
- Exufiber Gelling Fibre Dressing, Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre
- Keywords
- wound reduction wound healing, venous ulcers
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exufiber Gelling Fibre DressingDevice
Gelling fibre dressing
Aquacel Extra Hydrofiber® Dressing with Strengthening FibreDevice
Hydrofiber® Dressing with Strengthening Fibre
| Study group | Role | What they receive |
|---|---|---|
| Dressing Exufiber®Gelling Fibre Dressing | Experimental | will receive dressing Exufiber® Receives: Device: Exufiber Gelling Fibre Dressing |
| Dressing Aquacel®ExtraHydrofiber®Dressing with Strengthenin | Active comparator | Will receive Aquacel®Extra™ Receives: Device: Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Area Change (%)
The primary endpoint was to measure relative reduction of wound area (%) from baseline to end of investigation (up to 6 weeks measured by the validated system PictZar on the photos taken after debridement at week 0, week 4, and week 6 (or final visit if healed earlier)
Measured: 6 weeks
Secondary outcomes (6)
Wound Area Change (cm2)
The secondary endpoint was to measure relative reduction of wound area (cm2) from baseline to end of investigation (up to 6 weeks measured by the validated system PictZar on the photos taken after debridement at week 0, week 4, and week 6 (or final visit if healed earlier)
Measured: 6 weeks
Linear Advance of Wound Margin
Linear advance of the wound margin according to Gilman's formula (G= [(A0-An) / ((P0+Pn) / 2)] / Time) was calculated and evaluated using the validated system PictZar on the photos taken after debridement. The values represent wound margin advanced inwards over time (i.e., reduction in perimeter) presented in cm/day.
Measured: 6 weeks
Pain During Debridement
Pain was reported by patients and measured by Visual Analogue Scale (VAS) 0-100mm, where 0=is no pain, 100=is worst pain ever.
Measured: 6 weeks
Pain at Dressing Removal
Pain was reported by patients and measured by Visual Analogue Scale (VAS) 0-100mm, where 0=is no pain, 100=is worst pain ever.
Measured: 6 weeks
Percentage of Clinicians of Opinion 'Very Good' for Dressing Features
Clinician reported outcomed by means a questionnaire was used to capture opinions related to the two dressing types. Reply alternatives varied between very poor, poor, good, very good. Results reported as 'very good' are presented as a percentage based on all follow-up visits aggregated.
Measured: 6 weeks
Percentage of Clinicians of Opinion 'Does Not Adhere' Related to Dressing Features
Clinician reported outcomed by means a questionnaire was used to capture opinions related to the two dressing types. Reply alternatives varied between does not adhere, adhere a little, adhere a lot. Results reported as 'does not adhere' are presented as a percentage based on all follow-up visits aggregated.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion27 Nov 2019
- Study completion27 Nov 2019
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bo Joergensen, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921750
- Sponsor's protocol ID
- CHEXU03
- Acronym
- PD-497314
- Status last verified
- Oct 2020
- First submitted
- 19 Sep 2016
- Last updated
- 2 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Multi-centre Non-inferiority Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin
- ClinicalTrials.gov ID
- NCT02921750
- Acronym / sponsor ID
- PD-497314 / CHEXU03
- Conditions
- Venous Leg Ulcer
- Keywords
- wound reduction wound healing, venous ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 3 Oct 2016 (estimated)
- Results
- Posted 2 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigation is designed as an open, randomized, non-inferiority, multi-centre investigation.
212 evaluable subjects will be randomised. Subjects to be included will suffer from an exuding venous or mixed ulcer of predominantly venous origin. Subjects will either be randomized to Exufiber®Gelling Fibre Dressing or Aquacel®Extra Hydrofiber® Dressing with Strengthening Fibre using, centralized randomization
Detailed description
Visits are planned for baseline followed by 1, 2, 3, 4 and 6 weeks post treatment. The sub-group of at least 50 subjects will also be followed at week 8, 12, 16, 20, and 24 post treatment or until wound is healed if earlier.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dressing Exufiber®Gelling Fibre Dressing | Experimental | Device: Exufiber Gelling Fibre Dressingwill receive dressing Exufiber® |
| Dressing Aquacel®ExtraHydrofiber®Dressing with Strengthenin | Active comparator | Device: Aquacel Extra Hydrofiber® Dressing with Strengthening FibreWill receive Aquacel®Extra™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form
- Both gender ≥18 years old
- Ulcer moderately or strongly exudative justifying the use of an absorbent dressing
- (History of compression at least two weeks before inclusion) Deleted in Am.2
- (Wound covered with slough ≥70%) Deleted in Am.4
Key exclusion criteria (12 listed)
- Known allergy/hypersensitivity to the dressings
- Pregnant or breastfeeding
- Circumferential wounds (the entire wound should be able to be captured on a single image/photo)
- Subjects who will have problems following the protocol
- Subjects included in other ongoing clinical investigation evaluating wound dressings at present or during the past 30 days
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 Gelling Fibre DressingGelling fibre dressing | Device | Dressing Exufiber®Gelling Fibre Dressing |
| Aquacel Extra Hydrofiber® Dressing with Strengthening FibreHydrofiber® Dressing with Strengthening Fibre | Device | Dressing Aquacel®ExtraHydrofiber®Dressing with Strengthenin |
Primary outcome
Wound Area Change (%)
Time frame: 6 weeks
The primary endpoint was to measure relative reduction of wound area (%) from baseline to end of investigation (up to 6 weeks measured by the validated system PictZar on the photos taken after debridement at week 0, week 4, and week 6 (or final visit if healed earlier)
6 secondary outcomes
Wound Area Change (cm2)
Time frame: 6 weeks
Linear Advance of Wound Margin
Time frame: 6 weeks
Pain During Debridement
Time frame: 6 weeks
Pain at Dressing Removal
Time frame: 6 weeks
Percentage of Clinicians of Opinion 'Very Good' for Dressing Features
Time frame: 6 weeks
Percentage of Clinicians of Opinion 'Does Not Adhere' Related to Dressing Features
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Bo Joergensen, MD principal investigator
Bispebjerg Hospital
33 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exufiber Gelling Fibre Dressing and Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre in people with Venous Leg Ulcer, run by Molnlycke Health Care AB at 33 sites in 6 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 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 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Germany, Czechia, France, Sweden, Poland and 1 more country. 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 2 Nov 2020). 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?
Wound Area Change (%) (time frame: 6 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 2 Nov 2020.