Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dressing Exufiber®Gelling Fibre Dressing | Experimental | will receive dressing Exufiber® |
|
| Dressing Aquacel®ExtraHydrofiber®Dressing with Strengthenin | Active Comparator | Will receive Aquacel®Extra™ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exufiber Gelling Fibre Dressing | Device | Gelling fibre dressing |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Healed Wounds | Wound healing assessments were based on blind independent clinical review of photos. | from baseline to 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bo Joergensen, MD | Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Ann University Hospital Dep of Dermatovenereology | Brno | 656 91 | Czechia | |||
| Hospital Jihlava |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Exufiber | Investigational Device: Exufiber® gelling fibre dressing as primary dressing to facilitate moist healing of venous leg ulcer. |
| FG001 | Aquacel | Comparator - Aquacel® Extra™ Hydrofiber® Dressing with Strengthening Fibre as primary dressing to facilitate moist healing of venous leg ulcer. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2016 | Jun 4, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre | Device | Hydrofiber® Dressing with Strengthening Fibre |
|
| 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. |
| 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. | 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. | 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. | 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. | 6 weeks |
| Jihlava |
| 58601 |
| Czechia |
| Regional hospital Pardubice Dermatology Department | Pardubice | 53203 | Czechia |
| Fakultní nemocnice Královské Vinohrady (FNKV)Department of General Surgery 3 | Prague | 10034 | Czechia |
| General University Hospital in Prague | Prague | 128 08 | Czechia |
| Diabetologie | Soběslav | 39201 | Czechia |
| Salvatella LTD | Třinec | 739 61 | Czechia |
| Bispebjerg Hospital | Copenhagen | Copenhagen NV | 2200 | Denmark |
| Hôpital Michallon | Grenoble | 38043 | France |
| Groupe Hospitalier | La Rochelle | 17019 | France |
| Hospital Géneral du Mans | Le Mans | 72000 | France |
| Clinique du Parc Unité de Cicatrisation | Lyon | 69006 | France |
| CHU Nantes | Nantes | 44000 | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| Wundzentrum Augsburg | Augsburg | 86152 | Germany |
| WundZentrum Dortmund | Dortmund | 44137 | Germany |
| WundZentrum Düsseldorf | Düsseldorf | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Venenzentrum Freiburg | Freiburg im Breisgau | 79008 | Germany |
| Paracelsus-Klinik am Silbersee | Hanover | Germany |
| University Hospital Schleswig-Holstein | Kiel | 24105 | Germany |
| Johannes-Gutenberg-Universität Mainz | Mainz | 55131 | Germany |
| WundZentrum München Nord | München | 80939 | Germany |
| WundZentrum Ulm | Ulm | 89077 | Germany |
| Usługi Medyczne PRO-MED Sp. z o.o., ul. | Gliwice | 44-109 | Poland |
| Niepubliczny Zakład Opieki Zdrowotnej "GAM-MED", ul. | Kielce | 25-315 | Poland |
| Niepubliczny Zakład Opieki Zdrowotnej "Mikomed", ul. | Lodz | 94-238 | Poland |
| Medical Hair & Esthetic, ul. | Lublin | 20-844 | Poland |
| Lund university Hospital, | Lund | 22185 | Sweden |
| Avdelningen för kliniska prövningar, Universitetssjukhuset Örebro | Örebro | 70185 | Sweden |
| Skellefteå Lasarett | Skellefteå | 931 41 | Sweden |
| Karolinska Trial Alliance, Prim | Stockholm | 113 61 | Sweden |
| Södersjukhuset (Sårcentrum) | Stockholm | 118 83 | Sweden |
|
| Intention to Treat (ITT) |
|
| Per Protocol (PP) |
|
| Completed 6 Weeks Follow-up (PP) |
|
| Subgroup Followed for 24 Weeks (ITT) |
|
| Subgroup Followed for 24 Weeks (PP) |
|
| COMPLETED | Completed 6 weeks follow-up |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Exufiber | Investigational device: Exufiber Gelling fibre dressing |
| BG001 | Aquacel | Comparator: Aquacel® Extra™ Hydrofiber® Dressing with Strengthening Fibre |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Intention to treat population | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | PP analysis set, tested for non-inferiority | Posted | Median | Full Range | relative wound area change in percentage | 6 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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) | ITT analysis set | Posted | Mean | Standard Deviation | relative wound area change in cm2 | 6 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT analysis set. | Posted | Mean | Standard Deviation | cm/day | 6 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT analysis set | Posted | Mean | Standard Deviation | mm | 6 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT analysis set | Posted | Mean | Standard Deviation | mm | 6 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT analysis set. | Posted | Number | Percentage reported 'very good' | 6 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT analysis set. | Posted | Number | Percentage reported 'does not adhere' | 6 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Healed Wounds | Wound healing assessments were based on blind independent clinical review of photos. | Subgroup followed until healing or up to 24 weeks. | Posted | Number | Percentage of participants | from baseline to 24 weeks |
|
|
Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exufiber | Investigational device, Exufiber Gelling fibre dressing | 1 | 124 | 5 | 124 | 18 | 124 |
| EG001 | Aquacel | Comparator, Aquacel® Extra™ Hydrofiber® Dressing with Strengthening Fibre | 1 | 124 | 8 | 124 | 19 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture and hospitalisation | Injury, poisoning and procedural complications | Non-systematic Assessment | Patient was fallen down and broke her left arm. Of Cause of that she needs an Operation and was in hospital. |
| |
| Hip fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Heart failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Erysipelas right leg | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Gastric hemorrhage with hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Death | Renal and urinary disorders | Non-systematic Assessment | Death unknown cause in the Aquacel group. Death due to acute renal failure in the Exufiber group |
| |
| Pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Patient has increase pain, the wound status is going worse |
| |
| Infection exacerbated COPD | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Erysipelas PDK, hospitalize | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Intensification of depression | Psychiatric disorders | Non-systematic Assessment | Intensification of depression symptoms in course of schizophrenia |
| |
| Circulatory insufficiency with dehydration and dizziness | General disorders | Non-systematic Assessment |
| ||
| Congestive heart failure | Cardiac disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin reaction around the wound | Skin and subcutaneous tissue disorders | Systematic Assessment | Severe irritation around the wound. The dressing was done every 2 days with 2 Aquacel on the wound, contrary to the instructions of the protocol (a daily frequency with only 1 AQUACEL on the wound). |
| |
| Scheduled hernia surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| Infection at study wound | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Wound infection right leg | Skin and subcutaneous tissue disorders | Systematic Assessment | Wound infection right leg, and Increased redness in peri-wound skin. |
| |
| Increased wound liquid | Skin and subcutaneous tissue disorders | Systematic Assessment | The wound was covered with lots of blue-green-coloured slough, which Looks like pseudomonas |
| |
| Skin blister | Skin and subcutaneous tissue disorders | Systematic Assessment | Small skin blister and wound on the leg at the at area of dressing tape |
| |
| Aggravation of known psoriasis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Strong itching in the marginal area of the wound | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infection of the target ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Fall at home with wound in the right leg | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Headache, tiredness | General disorders | Systematic Assessment |
| ||
| Cough and inceased temperature | Infections and infestations | Systematic Assessment |
| ||
| Erysipel of nonstudy leg - left leg | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Burning, erhema of the scalp. | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Aquacel dressing intolerance (burn and redness) | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Increasing the ulcer with inflammatory reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| New ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Local infection in study wound | Infections and infestations | Systematic Assessment |
| ||
| Periwound skin irritation and blistering in study wound | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Flu infectious for 3 weeks | Infections and infestations | Systematic Assessment |
| ||
| Tooth Infection | Infections and infestations | Systematic Assessment |
| ||
| Redness and irritation on Periwound Skin on left leg study ulcer . | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Swollen right ankle/foot. | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Ulcer exacerbation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Stinging or burning while wearing study product | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Local signs of infection at the target wound | Infections and infestations | Systematic Assessment |
| ||
| Eczema with tingling and pain on right foot | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pain in back due to fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Stasis dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pain of the wound unrelated to the dressing | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Åberg Håkansson | Mölnlycke Health Care | +46 31722 3000 | maria.aberghakansson@molnlycke.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 28, 2017 | Oct 8, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
|
|
|
|
| Denmark |
|
|
| Poland |
|
|
| France |
|
|
| Germany |
|
|
| Sweden |
|
|
|
|
|
|
|
|
|