Venous leg ulcers Circulatory System Venous leg ulcers
Conditions
Interventions
Nurses offer an education programme to patients receiving usual care by their general practitioner (GP). In addition, the nurse specialist offers support to the medical doctor himself. The content of
Sponsors
Federal Ministry of Education and Research (Bundesministerium fuer Bildung und Forschung) (BMBF) / German Aerospace Center (DLR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients suffering from venous leg ulcers (stadium C6 according to CEAP classification) 2. Patients receiving treatment in a study practice 3. Patients have an ability of self-care (or the control of dependent care e.g. by relatives)
Exclusion criteria
Exclusion criteria: Exclusion criteria (before the study i.e.: no inclusion): 1. Other stadium of chronic venous insufficiency 2. Other etiology of the leg ulcer (e.g. arterial insufficiency, ulcus mixtum, diabetic foot) 3. Cognitive impairment (hindering self-care) 4. Insuffient competence of the German language 5. Inability to read 6. Parallel participation in another clinical trial Exclusion criteria (during the study): 1. Change of the general practitioner during the first six months after inclusion in the study 2. Ending of the study participation of the general practitioner 3. In-patient treatment (at least for 14 days) 4. Newly developed severe illness (hindering self-care)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 12 weeks (+/- two weeks)(t2): 1. Wound healing (proportion of healed leg ulcers) 2. Reduction of wound area (measured by digital planimetry) 3. Health-related quality of life (Freiburg Life Quality Assessment (FLQA), scale 1: physical complaints) | — |
Secondary
| Measure | Time frame |
|---|---|
| At six weeks (+/- one week)(t1), 12 weeks (+/- two weeks)(t2), 24 weeks (+/- four weeks)(t3) and 52 weeks (+/- four weeks)(t4) secondary outcomes: 1. Characteristics of healing (using the Leg Ulcer Measurement Tool [LUMT]) 2. Health-related quality of life using the FLQA 3. Self-care competence 4. Health economic evaluation (use of resources 5. Costs of the intervention 6. Satisfaction and personal opinion of all concerned subjects (patients, medical doctors and their teams, relatives, nurses) | — |
Countries
Germany
Outcome results
None listed