CEAP classification: vein symptoms only (C0s, C1s), primary varicose veins (C2p), varicose veins plus edema (C2p&C3), venous dermatopathy (C4) I83.9
Conditions
Interventions
Group 1: vein symptoms only (C0s, C1s)
Group 2: primary varicose veins (C2p)
Group 3: varicose veins plus edema (C2p&C3)
Group 4: venous dermatopathy (C4)
Sponsors
Bauerfeind AG
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients who fit the following criteria were included in the study: Patients with VS (vein symptoms) without clinical signs of venous disease or telangiectasia limited to the thigh (C0s, C1s), patients with varices, with or without VS (C2, C2s), patients with varices plus venous edema (C2 & C3), and patients with the dermatopathy of chronic venous insufficiency (C4).
Exclusion criteria
Exclusion criteria: Exclusion criteria include if patients were younger than 18 or older than 75; if they weighed over 120 kilos; if they were pregnant; if an acute venous condition (phlebitis, deep venous thrombosis, dermatitis) existed or a healed or florid venous ulceration (C5, C6) was found; if any health condition that could interfere with the study endpoints existed (e.g. arteriopathy, neuropathy, lymphedema, arthropathy, medication used which included analgesics or antirheumatics); if compression bandages or stockings were used on the day of the consultation; if a patient was unable to change rapidly from the recumbent position to the standing position and to keep this position for 10 minutes during the stress test; if patients were unable or unwilling to wear compression stockings; or if patients were unable or unwilling to complete the questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the result of the gravitational stress test which assesses both the increase in the volume of the lower legs and the emergence of symptoms after 10 minutes standing still. The test is performed first with bare legs, then with medical compression stockings. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is the type of symptoms experienced during the week before and during the week after consultation compared with the symtoms in the stress test . | — |
Countries
Germany
Contacts
Public ContactFelix Amsler
Amsler Consulting
Outcome results
None listed