No registrations found.
ID
Source
Health condition
diabetic foot ulcer
quality of life
cognitive behavior therapy
wound healing
diabetische voetwond
kwaliteit van leven
psychologische interventie
wondheling
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the result of Short form 36 (SF-36) measured 8 months after randomization.
Secondary outcome
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
Background summary
Rationale: The quality of life of patients with a diabetic foot ulcer is poor. This is due to physical limitations and emotional problems. Medical devices help patients overcome their physical limitations. However, there is no mental help program for these patients yet.
Objective: The aim of this study is to evaluate the effect of psychological intervention for the quality of life and wound healing in patients with a diabetic foot ulcer.
Study design: A single-center, randomized, prospective cohort study.
Study population: Patients visiting the multidisciplinary outpatient diabetic foot clinic with ≥ 1 foot ulcer on or below the malleolus, who are diagnosed with diabetes mellitus and aged between 18 and 65 years are eligible for inclusion.
Intervention: One group of patients will receive therapy for 45 minutes once a week for 8 weeks. The therapy is including cognitive behavioral therapy, lifestyle and stress management, coping behavior therapy and treatment for depression. The other group will not receive psychological therapy.
Main endpoints: The primary outcome is the score on the Short form 36 (SF-36) 6 months after finishing psychological intervention. Secondary outcomes are the result of Diabetic Foot Ulcer scale short form (DFS-SF) after finishing therapy and after 6 months follow-up, the occurrence of wound healing and the occurrence of minor and major amputation.
Study objective
The quality of life and wound healing of patients with a diabetic foot ulcer will improve after undergoing a psychological intervention.
Study design
8 months after randomization
Intervention
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 and treatment for depression. Hereafter, patients will complete the DFS-SF and SF-36 survey again.
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
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
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7406 |
| NTR-old | NTR7622 |
| CCMO | NL66883.029.18 |
| OMON | NL-OMON49780 |