Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-02-23 @ 1:31 AM
Study NCT ID:
NCT03429959
Status:
COMPLETED
Last Update Posted:
2019-06-27
First Post:
2017-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SOCKNLEG Compression Stocking Kit : User Friendliness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-26', 'studyFirstSubmitDate': '2017-12-15', 'studyFirstSubmitQcDate': '2018-02-05', 'lastUpdatePostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who completely don the two investigated leg compression devices', 'timeFrame': 'through study completion, within 7 months'}], 'secondaryOutcomes': [{'measure': 'Number of patients who completely doff the two investigated leg compression devices', 'timeFrame': 'through study completion, within 7 months'}, {'measure': 'Patient evaluation of user friendliness', 'timeFrame': '3 days', 'description': 'Evaluation of user friendliness using the ICC compression questionnaire'}, {'measure': 'Measuring oedema prevention of the compression stockings by comparison of leg volume measurement at V4 to V3 and V4 to V2.', 'timeFrame': '3 days', 'description': 'Assessment by measuring leg volume at the morning visit 3, compared to leg volume at the evening visit 4 and by comparing the leg volumes of visit 4 (compression) to visit 2 (no compression for 1 day)'}, {'measure': 'Time needed to don and doff the two investigated leg compression', 'timeFrame': '3 days', 'description': 'Time in minutes and seconds needed to don and doff each study stocking, measured by study investigator'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Venous Insufficiency of Leg']}, 'descriptionModule': {'briefSummary': 'The investigators aim to evaluate the user friendliness of a newly designed leg compression stocking kit, the SOCKNLEG, compared to a standard leg compression stocking of the same compression strength, the SIGVARIS Cotton. The SOCKNLEG is not yet commercially available, whereas the SIGVARIS Cotton has been successfully commercialized for many years.\n\nAfter an initial screening visit, a computer generated list will allocate the participants in either the SOCKNLEG or the SIGVARIS Cotton group.\n\nAll participants will try on both study stockings, in the order of their allocated group, and will rate their donning and doffing success with a questionnaire. The patients will then wear only the assigned study stocking of their allocated group, for a day and rate its comfort again at the end of the day. The donning and doffing success will also be rated by the study investigator. Leg volume measurements of the study leg will be taken at each visit to determine edema prevention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent as documented by signature\n* Male or postmenopausal female patient, aged over 65 years of age\n* Diagnosed venous insufficiency stage C3-C6 (according to CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic) -classification for venous diseases)\n\nExclusion Criteria:\n\n* Venous leg ulcer with a surface \\>5cm2\n* Peripheral artery disease (PAD) or media calcinosis (Ankle-Brachial-Index \\<0.8 or \\>1.3)\n* Difference in brachial blood pressure \\>20mmHg in both arms\n* Suspected polyneuropathy with ≥4 sensible test areas, measured with the Semmes-Weinstein-Monofilament-Test\n* Inability to reach the forefoot with their hands\n* Inability to follow the procedures of the study\n* Bed-ridden hospitalized patients who are not able to leave the bed or sit upright for a few consecutive hours'}, 'identificationModule': {'nctId': 'NCT03429959', 'acronym': 'SOCKNLEGZH', 'briefTitle': 'SOCKNLEG Compression Stocking Kit : User Friendliness', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'SOCKNLEG Compression Stocking Kit User Friendliness: Donning-Doffing-Edema Prevention An Open Monocentric Randomized Controlled Cross-over Trial', 'orgStudyIdInfo': {'id': 'SL1725'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SOCKNLEG', 'description': 'Donning and doffing success of the study stocking compared with both stockings, wearing of the study stocking for a day, standardized non invasive measurement to calculate leg volume of the study leg', 'interventionNames': ['Device: SOCKNLEG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SIGVARIS Cotton', 'description': 'Donning and doffing success of the study stocking compared with both stockings, wearing of the study stocking for a day, standardized non invasive measurement to calculate leg volume of the study leg', 'interventionNames': ['Device: SIGVARIS Cotton']}], 'interventions': [{'name': 'SOCKNLEG', 'type': 'DEVICE', 'description': 'Donning and doffing success compared with the two study stockings, wearing the assigned study stocking for a day, Patient Quesationnaire on donning and doffing success and wearing comfort of each study stocking', 'armGroupLabels': ['SOCKNLEG']}, {'name': 'SIGVARIS Cotton', 'type': 'DEVICE', 'description': 'SIGVARIS Cotton', 'armGroupLabels': ['SIGVARIS Cotton']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Department of Dermatology, University Hospital of Zurich, Switzerland', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Juerg Hafner, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}