chronic venous insufficiency I83.9
Conditions
Interventions
Group 1: Patient group 1 (25 patients):
Wearing of the normal compression stocking (Ccl II, AD) over a period of 28 days. The daily wearing time is 8 hours.
During the carrying phase, the patients mus
Sponsors
Bauerfeind AG - Phlebology Business Development & Medical Affairs
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) men and women between 18 and 80 years of age (2) the subject consent (3) Chronic Venous Insufficiency (Widmer St. I-IIIa, CEAP C1-5) (4) subject is free of health problems (E.g. acute infections) (5) subject is willing not to use any extra care products in the test area and use only a care-solids-free shower accessory provided by us
Exclusion criteria
Exclusion criteria: (1) non-CVI related leg edema (2) simultaneous participation in another study (3) deep vein thrombosis (4) arterial occlusive Disease (5) active florides ulcer (6) diabetes mellitus with neuropathy (7) pregnancy (8) inability to meet the criteria of the test plan (9) the subject has known allergies to any of the ingredients of the test substance (10) application of creams / care emulsions in the test area (11) non-existent mobility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visit 1 (start of study) und Visit 28 (end of study after 28 days): measurement of skin hydration and measurement of the transepidermal water loss of the skin by means of Tewameter and Corneometer | — |
Secondary
| Measure | Time frame |
|---|---|
| Visit 1 (start of study) und Visit 28 (end of study after 28 days): (1) measurement of the wear comfort with questionnaires 2)Skin roughness measurement by FOITS camera 3)PICO-press: fitting pressure between the compression stocking and skin 4)BT-600-measurement: measurement of volume of the legs | — |
Countries
Germany
Contacts
Public ContactManuela Reinhardt
Klinik und Poliklinik für Hautkrankheiten der Universitätsmedizin Greifswald
Outcome results
None listed