I87.2
Conditions
Interventions
Group 1: Compression System (Coban Fit) - Measurement of oedema reduction after 24 hours , measurement of ankle joint mobility with and without compression product
Group 2: Short-Stretch Bandage (Rosi
Sponsors
3M Deutschland GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Mobile males or females, age 18 years or older 2.Subjects having a chronic venous insufficiency (stage C3-C5 according to CEAP classification) 3.Subjects have pitting oedema 4.Duplex investigation proving superficial or deep obstruction and /or reflux 5.Subject has good joint mobility allowing exercises requested by the protocol 6.Subject has an Ankle Brachial Pressure Index ABPI (Ankle Brachial Pressure Index) = 0.8 7.Willing to give written informed consent and willing to comply with the study protocol
Exclusion criteria
Exclusion criteria: 1.Known pregnancy 2.Active leg ulcer 3.Peripheral arterial occlusive disease 4.Wearing of compression stockings less than 2 days prior to the scheduled study visits 5.Deep vein thrombosis in the last six months 6.Active cardiac disease or significant history of cardiac disease, 7.No change in oedema-reducing therapy (e.g. diuretics) one week before study start 8.Subjects who were, in the opinion of the investigator, unsuitable for enrolment in this study, for reasons not specified in the exclusion criteria. 9.Participation in any other prospective clinical study that can potentially interfere with this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of % volume reduction between start and after 24 hours with water displacement volumetry | — |
Secondary
| Measure | Time frame |
|---|---|
| Goniometer measurement of ankle joint mobility with and without compression product directly before and after application of the product | — |
Countries
Germany
Contacts
Public ContactWolfgang Vanscheidt
Dermatologie Freiburg
Outcome results
None listed