Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-05 @ 5:28 PM
Study NCT ID:
NCT02621632
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2015-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014689', 'term': 'Venous Insufficiency'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2015-05-22', 'studyFirstSubmitQcDate': '2015-12-01', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Donning success.', 'timeFrame': 'Successful donning has to be completed within 5 minutes.', 'description': 'Ability to fully done the investigated compression devices.'}], 'secondaryOutcomes': [{'measure': 'Interface pressure', 'timeFrame': 'Interface pressure is measured within 5 minutes of complete donning of the stocking.', 'description': 'Interface pressure of the compression systems is measured at level cB1 (transition of the Achilles tendon to the calf muscle) in mmHg by a pressure measuring device termed Picopress® . Interface pressure is compared between the novel compression system and the comparator, a class III compression stocking.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Compression therapy'], 'conditions': ['Venous Insufficiency']}, 'descriptionModule': {'briefSummary': 'The study intends to investigate a novel compression system termed Socknleg composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking.', 'detailedDescription': 'The investigator tests a novel compression system termed Socknleg in 20 healthy individuals and 20 patients with chronic venous disease. Socknleg is composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking. Outcome measures are successful donning and the comparison of interface pressure measured on the level of the ankle.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers: age \\> 18 years, proband information read, consent form signed\n* Patients: age \\> 18 years, chronic venous insufficiency CEAP C5 (healed venous ulcer).Age \\> 18 year, patient information read, consent signed.\n\nExclusion Criteria:\n\n* Active venous ulcer\n* Peripheral arterial disease\n* Peripheral neuropathy'}, 'identificationModule': {'nctId': 'NCT02621632', 'acronym': 'Socknleg', 'briefTitle': 'SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device', 'orgStudyIdInfo': {'id': 'KEK-ZH-Nr. 2013-091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy subjects and patients', 'description': 'To done a novel compression system. 20 healthy subjects and 20 patients done a novel compression system termed Socknleg and a compression class III stocking as a comparator.The Socknleg compression system was developed by the investigator and produced by Sigvaris AG, St. Gallen, Switzerland.', 'interventionNames': ['Device: (Socknleg)To done of a novel compression system']}], 'interventions': [{'name': '(Socknleg)To done of a novel compression system', 'type': 'DEVICE', 'description': 'To done a novel compression system.', 'armGroupLabels': ['Healthy subjects and patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Department of Dermatology, University Hospital of Zurich, Switzerland', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Juerg Hafner, Prof. (MD)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}