Venous Leg Ulcer Clinical Trial
— PD-497314Official 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
NCT number | NCT02921750 |
Other study ID # | CHEXU03 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | November 27, 2019 |
Verified date | October 2020 |
Source | Molnlycke Health Care AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 248 |
Est. completion date | November 27, 2019 |
Est. primary completion date | November 27, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form 2. Both gender =18 years old 3. Ulcer moderately or strongly exudative justifying the use of an absorbent dressing 4. (History of compression at least two weeks before inclusion) Deleted in Am.2 5. (Wound covered with slough =70%) Deleted in Am.4 6. 0.7=ABPI<1.3 7. Ulcer duration 6 weeks to 60 months 8. Ulcer size 3 cm2-100 cm2 9. Target ulcer at least 3 cm away from any other lesion Exclusion Criteria: 1. Known allergy/hypersensitivity to the dressings 2. Pregnant or breastfeeding 3. Circumferential wounds (the entire wound should be able to be captured on a single image/photo) 4. Subjects who will have problems following the protocol 5. Subjects included in other ongoing clinical investigation evaluating wound dressings at present or during the past 30 days 6. Patient with a systemic infection not controlled by suitable antibiotic treatment 7. Clinically infected wound according to the judgement of the investigator (heat, pain, swelling, redness or purulent secretion) 8. Wound covered with black necrosis 9. Dry wounds 10. Malignant wound degeneration 11. Current treatment with radiotherapy, chemotherapy, immunosuppressant drugs or high doses of oral corticosteroids if any 12. Subject with deep vein thrombosis within 3 months prior to inclusion |
Country | Name | City | State |
---|---|---|---|
Czechia | St. Ann University Hospital Dep of Dermatovenereology | Brno | |
Czechia | Hospital Jihlava | Jihlava | |
Czechia | Regional hospital Pardubice Dermatology Department | Pardubice | |
Czechia | Fakultní nemocnice Královské Vinohrady (FNKV)Department of General Surgery 3 | Prague | |
Czechia | General University Hospital in Prague | Prague | |
Czechia | Diabetologie | Sobeslav | |
Czechia | Salvatella LTD | Trinec | |
Denmark | Bispebjerg Hospital | Copenhagen | Copenhagen NV |
France | Hôpital Michallon | Grenoble | |
France | Groupe Hospitalier | La Rochelle | |
France | Hospital Géneral du Mans | Le Mans | |
France | Clinique du Parc Unité de Cicatrisation | Lyon | |
France | CHU Nantes | Nantes | |
France | Clinique Pasteur | Toulouse | |
Germany | Wundzentrum Augsburg | Augsburg | |
Germany | WundZentrum Dortmund | Dortmund | |
Germany | WundZentrum Düsseldorf | Düsseldorf | |
Germany | Universitätsklinikum Erlangen | Erlangen | |
Germany | Venenzentrum Freiburg | Freiburg | |
Germany | Paracelsus-Klinik am Silbersee | Hannover | |
Germany | University Hospital Schleswig-Holstein | Kiel | |
Germany | Johannes-Gutenberg-Universität Mainz | Mainz | |
Germany | WundZentrum München Nord | München | |
Germany | WundZentrum Ulm | Ulm | |
Poland | Uslugi Medyczne PRO-MED Sp. z o.o., ul. | Gliwice | |
Poland | Niepubliczny Zaklad Opieki Zdrowotnej "GAM-MED", ul. | Kielce | |
Poland | Niepubliczny Zaklad Opieki Zdrowotnej "Mikomed", ul. | Lódz | |
Poland | Medical Hair & Esthetic, ul. | Lublin | |
Sweden | Lund university Hospital, | Lund | |
Sweden | Avdelningen för kliniska prövningar, Universitetssjukhuset Örebro | Örebro | |
Sweden | Skellefteå Lasarett | Skellefteå | |
Sweden | Karolinska Trial Alliance, Prim | Stockholm | |
Sweden | Södersjukhuset (Sårcentrum) | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Molnlycke Health Care AB |
Czechia, Denmark, France, Germany, Poland, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Percentage of Participants With Healed Wounds | Wound healing assessments were based on blind independent clinical review of photos. | from baseline to 24 weeks | |
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) | 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) | 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. | 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. | 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. | 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. | 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. | 6 weeks |
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