diabetic foot ulcer quality of life cognitive behavior therapy wound healing diabetische voetwond kwaliteit van leven psychologische interventie wondheling
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age 18-65 years - Signed informed consent - Diagnosed with diabetes mellitus - ≥ 1 neuropathic foot ulcer (toe pressure > 70 mmHg) on or below the malleolus - Able to read and write Dutch - Attending outpatient diabetic foot clinic
Exclusion criteria
Exclusion criteria: Living in a nursing home - Diagnosed with alzheimer’s disease - Diagnosed with vascular dementia - Diagnosed with lewy body dementia - Diagnosed with frontotemporal dementia - Diagnosed with amyotrophic lateral sclerosis - Diagnosed with Parkinson’s disease - Life expectancy ≤ 1 year, in the investigator’s opinion - Diagnosed with schizophrenia - Diagnosed with schizoaffective disorder - Diagnosed with schizophreniform disorder - Diagnosed with bipolar disorder - Diagnosed with delusional disorder - Diagnosed with brief psychotic disorder - Diagnosed with folie à deux
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the result of Short form 36 (SF-36) measured 8 months after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: 1. SF-36 results measured 2 months after randomization 2. Diabetic Foot Ulcer scale short form (DFS-SF) results measured 2 months after randomization 3. DFS-SF results measured 8 months after randomization 4. occurrence of wound healing 5. minor amputation rate 6. major amputation rate | — |