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The effect of psychological intervention on the quality of life and wound healing in patients with diabetic foot ulcer.

The effect of psychological intervention on the quality of life and wound healing in patients with diabetic foot ulcer.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27954
Enrollment
40
Registered
2018-11-06
Start date
2019-01-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic foot ulcer quality of life cognitive behavior therapy wound healing diabetische voetwond kwaliteit van leven psychologische interventie wondheling

Interventions

A medical psychologist will perform therapy for 45 minutes 2 times a week for 8 weeks. The therapy is including cognitive behavioral therapy, lifestyle and stress management, coping behavior therapy a

Sponsors

Northwest Clinics
Lead Sponsor

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

MeasureTime frame
The primary outcome is the result of Short form 36 (SF-36) measured 8 months after randomization.

Secondary

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)