Practicability of Gliding Aids for Medical Compression Stockings
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 2, 2011 | ||||||||
| Last Updated Date | April 13, 2012 | ||||||||
| Start Date ICMJE | November 2010 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Number of successfully dressed medical stockings per subject [ Time Frame: Per subject: 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01432795 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Patient satisfaction by gliding aid or stocking butler (score) [ Time Frame: Per subject 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months ] [ Designated as safety issue: No ] Patients are asked to score each gliding aid and each stocking "butler" with a mark between "1" (bad) and "6" (very good). |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Practicability of Gliding Aids for Medical Compression Stockings | ||||||||
| Official Title ICMJE | Gliding Aids for Medical Compression Stockings - Practicability in Elderly Patients With Chronic Venous Insufficiency | ||||||||
| Brief Summary | 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. The 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. |
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| Detailed Description | Subjects: 40 consenting patients >65y old, with CEAP C4-6 chronic venous insufficiency Stockings: One class 3 (36 - 46 mmHg interface pressure) with closed tip One class 3 with open tip Two superimposed class 1 (18 - 21 mmHg) Gliding 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 |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Gliding aids for medical compression stockings
Each subject tests devices:
Other Names:
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| Study Arm (s) | Experimental: Test series of 6 types of gliding aids
Each study subjects tests a series of gliding aids or stocking butlers:
Intervention: Device: Gliding aids for medical compression stockings |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | June 2012 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: > 65 years old Chronic venous insufficiency CEAP C4-6 Exclusion Criteria: Dementia Blindness Paraplegia |
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| Gender | Both | ||||||||
| Ages | 65 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01432795 | ||||||||
| Other Study ID Numbers ICMJE | KEK-ZH2010-0329/5 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University of Zurich | ||||||||
| Study Sponsor ICMJE | University of Zurich | ||||||||
| Collaborators ICMJE | JH Rahn Foundation, Zurich | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Zurich | ||||||||
| Verification Date | September 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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