Tightening behaviour of compression stockings of Ccl 1 A-D with and without tightening aid in comparison to compression stockings of Ccl 2 A-D and compared to commercially available Kneestockings in people of higher age and movement restrictions as well as an analisis of their wearing-behaviour/comfort (wear test)
- Conditions
- R60.9ORTHOSTATISCHEDEMEOedema, unspecified
- Registration Number
- DRKS00011193
- Lead Sponsor
- Eurocom e.V.Ansprechpartner- Dr. Thomä- Bauerfeind AG - Phlebology - Business Development & Medical Affairs; Triebeserstr. 1607937 Zeulenroda/Thür
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 19
• both sexes
• Orthostatic leg-edema
• Age over 65 years
• Presence of at least one disorder characterized by movement limitation and low mobility (joint diseases: disorders of rheumatic shape, arthrosis, hipprothesis , muscular diseases with muscular weakness and / or polyneuropathy, obesity / cachexia)
• willingness and ability to wear compression stockings as well as to the doctor's instructions and to keep the planned visits
• Presence of written consent to participate in the study after a thorough investigation into the nature, significance, risks and scope of the clinical trial as well as expected expected and undesirable effects of the trials.
• Adequate German language skills both verbal and written.
• Age under 65 years
• lack of movement restriction
• acute deep venous thrombosis
• clinically relevant peripheral arterial occlusive disease stage II-IV according to Fontaine
• Paralysis
• Dementia
• Pregnancy
• Unsigned consent
• Participation in another study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method tightening and correct positioning of the compression stockings Ccl1 and Ccl 2 as well as of the convential knee-stocking without and with a tightening aid <br>after each dressing-complexe quesionairs are used, they are developed at the clinicl center; questionaired will be for example fatigue of the patient, the correct position of the stocking on the patient's leg and assessment of the time and effort required, etc.
- Secondary Outcome Measures
Name Time Method 1.) Success rate of the tightenng and 2.) Time requirement of the creation in relation to:<br>• Age<br>• Gender<br>• Body Mass Index (BMI)<br>• Waist circumference<br>• Movement restrictions given by the basic diseases according to the inclusion criteria<br>• Ability to reach the forefoot by hand<br>• hand-force on both sides<br>• Tensile force = force required to pull a compression stocking over the heel<br>Questionnaires for the subjective assessment of the attractiveness of all test products<br><br>3) Determining the wearing-behaviour/comfort by using questionairs e.g. about redness, pressure points, constriction, pain, etc.