I83.2
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: patients over 18 years with ulcers of the lower legs of predominantly venous genesis (brachio-pedal index >0.6, wedge pressures >60 mm Hg); chronic state (lasting more than 6 weeks with no tendency to heal under the previous therapy); ulcer size of 1–200 cm².
Exclusion criteria
Exclusion criteria: vascular surgical or other vascular interventions in the area of the lower extremities within the last 6 weeks prior to inclusion in the study; prior inclusion in this study; inclusion in an other study at the time of inclusion in this study;physical or mental illnesses (including severe accompanying basic illnesses, e.g. cancer, AIDS, severe anaemia, insufficiently treated diabetes mellitus) which do not allow participation in the treatment procedure of the study; peripheral arterial occlusive disease (with clinical signs for a critical ischaemia, a brachio-pedal index <0.6 or a wedge pressure of the ankle or arch of the foot <60 mm Hg); oral antibiotic treatment of the ulcer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound closure or wound size reduction of a treatment intervall of maximum 13 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of wound exsudation, pain, granulation, coatings, epithelialization during therapy. | — |
Countries
Germany
Contacts
Universitäts-Hautklinik