Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT01591434
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2012-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007871', 'term': 'Leg Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-29', 'studyFirstSubmitDate': '2012-05-02', 'studyFirstSubmitQcDate': '2012-05-02', 'lastUpdatePostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wear Time', 'timeFrame': '4 weeks', 'description': 'frequency of dressing changes'}, {'measure': 'Wear Time', 'timeFrame': '4 weeks', 'description': 'Reason for dressing changes'}, {'measure': '% of dressings achieving a 7 day wear time', 'timeFrame': '4 weeks'}, {'measure': 'Time to achieve a 7 day wear time', 'timeFrame': '4 weeks'}, {'measure': 'Condition of the peri-ulcer skin', 'timeFrame': '4 weeks', 'description': 'Improvement from baseline in the condition of the peri-ulcer skin'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Leg Ulcer']}, 'descriptionModule': {'briefSummary': 'Based upon the in-vitro data AQUACEL® Extra™ achieves a 39% increase in absorbency. As such it is anticipated that through improved exudate management a longer wear time will be achieved in the AQUACEL® Extra™ group compared to AQUACEL® in the management of chronic wounds such as venous leg ulcers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects over 18 years, willing and able to provide written informed consent.\n* Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater\n* Subjects who have a venous leg ulcer (i.e. CEAP classification of C6 1) with duration less than 24 months\n* Subjects whose ulcer is no smaller than 2cms in any one direction\n* Subjects whose ulcer is no greater than 11cm in any one direction (measured by longest length and widest width)\n* Subjects' whose index leg ulcer has a moderate to heavy level of exudate.\n* Subjects whose index (study) leg is currently being treated with compression therapy and whose leg oedema is under control\n* Subjects who are willing and able to comply with the requirements of the clinical investigation plan in relation to the dressing/compression regime and the ability to attend dressing changes as required.\n\nExclusion Criteria:\n\n* Subjects with a history of skin sensitivity to any of the components of the study dressings (AQUACEL® Extra™, AQUACEL®, \\& DuoDERM™ Extra Thin)\n* Subjects whose wounds are considered clinically infected at baseline\n* Subjects whose leg ulcers are malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.\n* Subjects who have progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents\n* Subjects exhibiting any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study\n* Subjects who have participated in a clinical study within the past month."}, 'identificationModule': {'nctId': 'NCT01591434', 'briefTitle': 'Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'ConvaTec Inc.'}, 'officialTitle': 'An Open Randomised Comparative Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers', 'orgStudyIdInfo': {'id': 'CW-0209-11-U361'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AQUACEL®', 'description': 'A sterile non-woven sheet of sodium carboxymethylcellulose (NaCMC).', 'interventionNames': ['Device: AQUACEL®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AQUACEL® Extra™', 'description': 'A sandwiched construction of two layers of optimally textiled non-woven fabric, stitch-bonded together using Lyocel (Tencel™ regenerated cellulose) yarns.', 'interventionNames': ['Device: AQUACEL® Extra™']}], 'interventions': [{'name': 'AQUACEL®', 'type': 'DEVICE', 'description': 'Dressing to be changed as clinically needed or at least every seven days.', 'armGroupLabels': ['AQUACEL®']}, {'name': 'AQUACEL® Extra™', 'type': 'DEVICE', 'description': 'Dressing to be changed as clinically needed or at least every seven days.', 'armGroupLabels': ['AQUACEL® Extra™']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79100', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Dermatologische Gemeinschaftspraxis', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Bramfelder Chaussee', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '6401 CX', 'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Mitralis Expertise Centrum', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'zip': '90-553', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Nzoz Certus', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '03-983', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'CF Centrum Flebologii Anna i Beata Narojczyk', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '18, 02-366', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Continuum Care', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '41-819', 'city': 'Zabrze', 'country': 'Poland', 'facility': 'Medyczna "Medservice"', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}, {'zip': 'CH49 5PE', 'city': 'Upton', 'state': 'Wirral', 'country': 'United Kingdom', 'facility': 'Arrowe Park Hospital,', 'geoPoint': {'lat': 53.61466, 'lon': -1.28677}}, {'zip': 'BD9 6RJ', 'city': 'Bradford', 'country': 'United Kingdom', 'facility': 'Bradford Teaching Hospitals', 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'zip': 'CF14 4XN', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Wound Healing Research Unit, Cardiff University', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'BN21 4RL', 'city': 'Eastbourne', 'country': 'United Kingdom', 'facility': 'Tissue Viability Consultancy Services Ltd', 'geoPoint': {'lat': 50.76871, 'lon': 0.28453}}, {'zip': 'WV12 5PR', 'city': 'Willenhall', 'country': 'United Kingdom', 'facility': 'Walsall Healthcare NHS Trust Short Heath Clinic', 'geoPoint': {'lat': 52.58514, 'lon': -2.05934}}], 'overallOfficials': [{'name': 'Keith G Harding', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiff University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ConvaTec Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}