Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-25 @ 5:56 AM
Study NCT ID:
NCT02921750
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2016-09-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maria.aberghakansson@molnlycke.com', 'phone': '+46 31722 3000', 'title': 'Maria Åberg Håkansson', 'organization': 'Mölnlycke Health Care'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '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', 'eventGroups': [{'id': 'EG000', 'title': 'Exufiber', 'description': 'Investigational device, Exufiber Gelling fibre dressing', 'otherNumAtRisk': 124, 'deathsNumAtRisk': 124, 'otherNumAffected': 18, 'seriousNumAtRisk': 124, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Aquacel', 'description': 'Comparator, Aquacel® Extra™ Hydrofiber® Dressing with Strengthening Fibre', 'otherNumAtRisk': 124, 'deathsNumAtRisk': 124, 'otherNumAffected': 19, 'seriousNumAtRisk': 124, 'deathsNumAffected': 1, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Skin reaction around the wound', 'notes': '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).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scheduled hernia surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection at study wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound infection right leg', 'notes': 'Wound infection right leg, and Increased redness in peri-wound skin.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased wound liquid', 'notes': 'The wound was covered with lots of blue-green-coloured slough, which Looks like pseudomonas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin blister', 'notes': 'Small skin blister and wound on the leg at the at area of dressing tape', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aggravation of known psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Strong itching in the marginal area of the wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection of the target ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall at home with wound in the right leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache, tiredness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough and inceased temperature', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erysipel of nonstudy leg - left leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Burning, erhema of the scalp.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aquacel dressing intolerance (burn and redness)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increasing the ulcer with inflammatory reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Local infection in study wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Periwound skin irritation and blistering in study wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu infectious for 3 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness and irritation on Periwound Skin on left leg study ulcer .', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swollen right ankle/foot.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulcer exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stinging or burning while wearing study product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Local signs of infection at the target wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema with tingling and pain on right foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in back due to fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stasis dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain of the wound unrelated to the dressing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Fracture and hospitalisation', 'notes': 'Patient was fallen down and broke her left arm. Of Cause of that she needs an Operation and was in hospital.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erysipelas right leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric hemorrhage with hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'notes': 'Death unknown cause in the Aquacel group. Death due to acute renal failure in the Exufiber group', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'Patient has increase pain, the wound status is going worse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection exacerbated COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erysipelas PDK, hospitalize', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intensification of depression', 'notes': 'Intensification of depression symptoms in course of schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Circulatory insufficiency with dehydration and dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Wound Area Change (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exufiber', 'description': 'Investigational device, Exufiber Gelling Fibre Dressing'}, {'id': 'OG001', 'title': 'Aquacel', 'description': 'Comparator, Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre'}], 'classes': [{'categories': [{'measurements': [{'value': '-49.7', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '191.2'}, {'value': '-42.4', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '1538.4'}]}]}], 'analyses': [{'pValue': '0.093', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29.4', 'ciLowerLimit': '-63.5', 'ciUpperLimit': '3.2', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': "In this non-inferiority study the primary efficacy analysis included constructing a two sided 95% confidence interval, using Fisher's non-parametric permutation test, for between-treatment differences (Exufiber - Aquacel Extra) in the mean percentage area change from baseline to 6 weeks. This means that if the lower limit of this confidence interval was found to be greater than 12%, non-inferiority will be established."}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': '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)', 'unitOfMeasure': 'relative wound area change in percentage', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PP analysis set, tested for non-inferiority'}, {'type': 'SECONDARY', 'title': 'Wound Area Change (cm2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exufiber', 'description': 'Investigational device, Exufiber Gelling Fibre Dressing'}, {'id': 'OG001', 'title': 'Aquacel', 'description': 'Comparator, Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.64', 'spread': '7.73', 'groupId': 'OG000'}, {'value': '-3.48', 'spread': '7.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': '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)', 'unitOfMeasure': 'relative wound area change in cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set'}, {'type': 'SECONDARY', 'title': 'Linear Advance of Wound Margin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exufiber', 'description': 'Investigational Device, Exufiber Gelling Fibre Dressing'}, {'id': 'OG001', 'title': 'Aquacel', 'description': 'Comparator, Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre'}], 'classes': [{'categories': [{'measurements': [{'value': '0.008', 'spread': '0.010', 'groupId': 'OG000'}, {'value': '0.007', 'spread': '0.010', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': "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.", 'unitOfMeasure': 'cm/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set.'}, {'type': 'SECONDARY', 'title': 'Pain During Debridement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exufiber', 'description': 'Investigational Device, Exufiber Gelling Fibre Dressing'}, {'id': 'OG001', 'title': 'Aquacel', 'description': 'Comparator, Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre'}], 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '26.9', 'spread': '29.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Pain was reported by patients and measured by Visual Analogue Scale (VAS) 0-100mm, where 0=is no pain, 100=is worst pain ever.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set'}, {'type': 'SECONDARY', 'title': 'Pain at Dressing Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exufiber', 'description': 'Investigational device, Exufiber Gelling Fibre Dressing'}, {'id': 'OG001', 'title': 'Aquacel', 'description': 'Comparator, Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre'}], 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '22.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Pain was reported by patients and measured by Visual Analogue Scale (VAS) 0-100mm, where 0=is no pain, 100=is worst pain ever.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set'}, {'type': 'SECONDARY', 'title': "Percentage of Clinicians of Opinion 'Very Good' for Dressing Features", 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exufiber', 'description': 'Investigational device, Exufiber Gelling fibre dressing'}, {'id': 'OG001', 'title': 'Aquacel', 'description': 'Comparator, Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre'}], 'classes': [{'title': 'Ease of application of dressing', 'categories': [{'measurements': [{'value': '58.4', 'groupId': 'OG000'}, {'value': '57.5', 'groupId': 'OG001'}]}]}, {'title': 'Ease of removal of dressing', 'categories': [{'measurements': [{'value': '48.7', 'groupId': 'OG000'}, {'value': '35.9', 'groupId': 'OG001'}]}]}, {'title': 'Flexibility of dressing', 'categories': [{'measurements': [{'value': '48.0', 'groupId': 'OG000'}, {'value': '40.8', 'groupId': 'OG001'}]}]}, {'title': 'Overall experience of dressing', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '32.5', 'groupId': 'OG001'}]}]}, {'title': 'Conformability to the wound', 'categories': [{'measurements': [{'value': '39.9', 'groupId': 'OG000'}, {'value': '36.2', 'groupId': 'OG001'}]}]}, {'title': 'Ability to Absorb Exudates', 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000'}, {'value': '32.3', 'groupId': 'OG001'}]}]}, {'title': 'Ability to Retain Exudate', 'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000'}, {'value': '31.7', 'groupId': 'OG001'}]}]}, {'title': 'Ability to Absorb Blood', 'categories': [{'measurements': [{'value': '38.4', 'groupId': 'OG000'}, {'value': '32.5', 'groupId': 'OG001'}]}]}, {'title': 'Ability to Keep Blood and Slough', 'categories': [{'measurements': [{'value': '36.3', 'groupId': 'OG000'}, {'value': '28.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': "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.", 'unitOfMeasure': "Percentage reported 'very good'", 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set.'}, {'type': 'SECONDARY', 'title': "Percentage of Clinicians of Opinion 'Does Not Adhere' Related to Dressing Features", 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exufiber', 'description': 'Investigational device, Exufiber Gelling fibre dressing'}, {'id': 'OG001', 'title': 'Aquacel', 'description': 'Comparator, Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre'}], 'classes': [{'title': 'Non-adherence to wound bed at removal', 'categories': [{'measurements': [{'value': '44.2', 'groupId': 'OG000'}, {'value': '31.1', 'groupId': 'OG001'}]}]}, {'title': 'Non-adherence to peri-wound skin at removal', 'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000'}, {'value': '52.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': "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.", 'unitOfMeasure': "Percentage reported 'does not adhere'", 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Healed Wounds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exufiber', 'description': 'Investigational device, Exufiber Gelling fibre dressing'}, {'id': 'OG001', 'title': 'Aquacel', 'description': 'Comparator Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '47.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from baseline to 24 weeks', 'description': 'Wound healing assessments were based on blind independent clinical review of photos.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subgroup followed until healing or up to 24 weeks.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exufiber', 'description': 'Investigational Device: Exufiber® gelling fibre dressing as primary dressing to facilitate moist healing of venous leg ulcer.'}, {'id': 'FG001', 'title': 'Aquacel', 'description': 'Comparator - Aquacel® Extra™ Hydrofiber® Dressing with Strengthening Fibre as primary dressing to facilitate moist healing of venous leg ulcer.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Safety population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'Intention to Treat (ITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'Per Protocol (PP)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'Completed 6 Weeks Follow-up (PP)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'Subgroup Followed for 24 Weeks (ITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'Subgroup Followed for 24 Weeks (PP)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'comment': 'Completed 6 weeks follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Wound healed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exufiber', 'description': 'Investigational device: Exufiber Gelling fibre dressing'}, {'id': 'BG001', 'title': 'Aquacel', 'description': 'Comparator: Aquacel® Extra™ Hydrofiber® Dressing with Strengthening Fibre'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70.0', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '69.0', 'spread': '15.0', 'groupId': 'BG001'}, {'value': '69.5', 'spread': '13.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Czechia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Intention to treat population'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-08', 'size': 857828, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-06-04T05:13', 'hasProtocol': False}, {'date': '2017-12-28', 'size': 834205, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-08T16:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-08', 'studyFirstSubmitDate': '2016-09-19', 'resultsFirstSubmitDate': '2020-08-26', 'studyFirstSubmitQcDate': '2016-09-30', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-08', 'studyFirstPostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Healed Wounds', 'timeFrame': 'from baseline to 24 weeks', 'description': 'Wound healing assessments were based on blind independent clinical review of photos.'}], 'primaryOutcomes': [{'measure': 'Wound Area Change (%)', 'timeFrame': '6 weeks', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Wound Area Change (cm2)', 'timeFrame': '6 weeks', 'description': '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)'}, {'measure': 'Linear Advance of Wound Margin', 'timeFrame': '6 weeks', 'description': "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."}, {'measure': 'Pain During Debridement', 'timeFrame': '6 weeks', 'description': 'Pain was reported by patients and measured by Visual Analogue Scale (VAS) 0-100mm, where 0=is no pain, 100=is worst pain ever.'}, {'measure': 'Pain at Dressing Removal', 'timeFrame': '6 weeks', 'description': 'Pain was reported by patients and measured by Visual Analogue Scale (VAS) 0-100mm, where 0=is no pain, 100=is worst pain ever.'}, {'measure': "Percentage of Clinicians of Opinion 'Very Good' for Dressing Features", 'timeFrame': '6 weeks', 'description': "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."}, {'measure': "Percentage of Clinicians of Opinion 'Does Not Adhere' Related to Dressing Features", 'timeFrame': '6 weeks', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['wound reduction wound healing, venous ulcers'], 'conditions': ['Venous Leg Ulcer']}, 'descriptionModule': {'briefSummary': 'The investigation is designed as an open, randomized, non-inferiority, multi-centre investigation.\n\n212 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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form\n2. Both gender ≥18 years old\n3. Ulcer moderately or strongly exudative justifying the use of an absorbent dressing\n4. (History of compression at least two weeks before inclusion) Deleted in Am.2\n5. (Wound covered with slough ≥70%) Deleted in Am.4\n6. 0.7≤ABPI\\<1.3\n7. Ulcer duration 6 weeks to 60 months\n8. Ulcer size 3 cm2-100 cm2\n9. Target ulcer at least 3 cm away from any other lesion\n\nExclusion Criteria:\n\n1. Known allergy/hypersensitivity to the dressings\n2. Pregnant or breastfeeding\n3. Circumferential wounds (the entire wound should be able to be captured on a single image/photo)\n4. Subjects who will have problems following the protocol\n5. Subjects included in other ongoing clinical investigation evaluating wound dressings at present or during the past 30 days\n6. Patient with a systemic infection not controlled by suitable antibiotic treatment\n7. Clinically infected wound according to the judgement of the investigator (heat, pain, swelling, redness or purulent secretion)\n8. Wound covered with black necrosis\n9. Dry wounds\n10. Malignant wound degeneration\n11. Current treatment with radiotherapy, chemotherapy, immunosuppressant drugs or high doses of oral corticosteroids if any\n12. Subject with deep vein thrombosis within 3 months prior to inclusion'}, 'identificationModule': {'nctId': 'NCT02921750', 'acronym': 'PD-497314', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Molnlycke Health Care AB'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CHEXU03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dressing Exufiber®Gelling Fibre Dressing', 'description': 'will receive dressing Exufiber®', 'interventionNames': ['Device: Exufiber Gelling Fibre Dressing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dressing Aquacel®ExtraHydrofiber®Dressing with Strengthenin', 'description': 'Will receive Aquacel®Extra™', 'interventionNames': ['Device: Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre']}], 'interventions': [{'name': 'Exufiber Gelling Fibre Dressing', 'type': 'DEVICE', 'description': 'Gelling fibre dressing', 'armGroupLabels': ['Dressing Exufiber®Gelling Fibre Dressing']}, {'name': 'Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre', 'type': 'DEVICE', 'description': 'Hydrofiber® Dressing with Strengthening Fibre', 'armGroupLabels': ['Dressing Aquacel®ExtraHydrofiber®Dressing with Strengthenin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '656 91', 'city': 'Brno', 'country': 'Czechia', 'facility': 'St. Ann University Hospital Dep of Dermatovenereology', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '58601', 'city': 'Jihlava', 'country': 'Czechia', 'facility': 'Hospital Jihlava', 'geoPoint': {'lat': 49.3961, 'lon': 15.59124}}, {'zip': '53203', 'city': 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