Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-27 @ 10:16 PM
Study NCT ID:
NCT01432795
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2011-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Practicability of Gliding Aids for Medical Compression Stockings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054070', 'term': 'Postthrombotic Syndrome'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}], 'ancestors': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014689', 'term': 'Venous Insufficiency'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-21', 'studyFirstSubmitDate': '2011-05-02', 'studyFirstSubmitQcDate': '2011-09-09', 'lastUpdatePostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of successfully dressed medical stockings per subject', 'timeFrame': 'Per subject: 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months', 'description': 'The primary end point is straight: The medical stocking is dressed (at the patient\'s leg) or it is not dressed. Each gliding aid and each stocking "butler" is tested with this end point.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction by gliding aid or stocking butler (score)', 'timeFrame': 'Per subject 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months', 'description': 'Patients are asked to score each gliding aid and each stocking "butler" with a mark between "1" (bad) and "6" (very good).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic venous insufficiency', 'post-thrombotic syndrome', 'medical compression therapy', 'compression stocking', 'gliding aid', 'stocking butler', 'adherence to treatment'], 'conditions': ['Chronic Venous Insufficiency', 'Post-thrombotic Syndrome']}, 'referencesModule': {'references': [{'pmid': '25579875', 'type': 'DERIVED', 'citation': 'Sippel K, Seifert B, Hafner J. Donning devices (foot slips and frames) enable elderly people with severe chronic venous insufficiency to put on compression stockings. Eur J Vasc Endovasc Surg. 2015 Feb;49(2):221-9. doi: 10.1016/j.ejvs.2014.11.005. Epub 2015 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'Medical compression stockings are highly effective in the prevention, treatment, and secondary prevention of chronic venous insufficiency and of post-thrombotic syndrome. Non-adherence to the prescribed compression treatment concerns approximately 40% of patients. Elderly patients are often unable to handle stockings in order to put them on properly in the morning and to undress in the evening. Gliding aids and stocking "butlers" are two types of tools to facilitate the dressing manoeuvre with medical stockings.\n\nThe present study evaluates four different gliding aids and two different stocking "butlers" to put on three different types of compression stockings. The study is conducted with forty consenting subjects with advanced chronic venous insufficiency.', 'detailedDescription': 'Subjects: 40 consenting patients \\>65y old, with CEAP C4-6 chronic venous insufficiency\n\nStockings:\n\nOne class 3 (36 - 46 mmHg interface pressure) with closed tip One class 3 with open tip Two superimposed class 1 (18 - 21 mmHg)\n\nGliding aids and stocking "butlers" Three types of gliding aids for closed tip stockings Three types of gliding aids for open tip stockings Two types of stocking "butlers", one optional with mounted handles'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\> 65 years old Chronic venous insufficiency CEAP C4-6\n\nExclusion Criteria:\n\nDementia Blindness Paraplegia'}, 'identificationModule': {'nctId': 'NCT01432795', 'briefTitle': 'Practicability of Gliding Aids for Medical Compression Stockings', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Gliding Aids for Medical Compression Stockings - Practicability in Elderly Patients With Chronic Venous Insufficiency', 'orgStudyIdInfo': {'id': 'KEK-ZH2010-0329/5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test series of 6 types of gliding aids', 'description': 'Each study subjects tests a series of gliding aids or stocking butlers:\n\n* 4 gliding aids\n* 2 stocking "butlers", one with and without handle\n* 3 medical compression stockings with open tip, compression class 3 (36-46mmHg)\n* 3 medical compression stockings w. closed tip, compression class 3 (36-46mmHg)\n* 2 superimposed stockings with closed tip, compression class 1 (18-21 mmHg)', 'interventionNames': ['Device: Gliding aids for medical compression stockings']}], 'interventions': [{'name': 'Gliding aids for medical compression stockings', 'type': 'DEVICE', 'otherNames': ['Gliding aids:', 'Easy Slide (Sigvaris)', 'Easy Slide Caran (Sigvaris)', 'Venotrain Glider (Bauerfeind)', 'Blue Standard Foot Slip (Bauerfeind)', 'Easy Glide (Eureka) (Salzmann)', 'Socks Jet with and without handle (Salzmann)', 'Mediven Butler (Cosanum)'], 'description': 'Each subject tests devices:\n\n* 3 gliding aids for stockings with closed tips\n* 3 gliding aids for stockings with open tips\n* 2 stocking butlers using\n* 3 medical compression stockings with open tip, compression class 3 (36-46mmHg)\n* 3 medical compression stockings w. closed tip, compression class 3 (36-46mmHg)\n* 2 superimposed compression stockings class 1 (18 - 21 mmHg)', 'armGroupLabels': ['Test series of 6 types of gliding aids']}]}, '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': 'Jürg Hafner, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, University Hospital of Zurich, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'JH Rahn Foundation, Zurich', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}