The aim of this study is to evaluate the effect of psychological intervention on the quality of life and wound healing in patients with a foot ulcer.
ID
Source
Brief title
Condition
- Skin vascular abnormalities
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the score on the Short form 36 (SF-36) measured at the
second follow-up moment (6 months (+/- 2 months) after therapy for the
intervention group and 12 months (+/- 2 months) after randomization for the
control group).
Secondary outcome
Secondary endpoints are:
1. SF-36 results at the first follow up moment (at the end of therapy for the
intervention group and 6 months after randomization for the control group)
2. Diabetic Foot Ulcer scale short form (DFS-SF) results at the first follow-up
moment.
3. DFS-SF results at the second follow-up moment.
4. Occurrence of wound healing at the second follow-up moment.
5. minor amputation rate
6. major amputation rate
Background summary
Research has shown a significant association with diabetic foot ulcer and
mental health symptoms. When the quality of life in patients with diabetic foot
ulcer are measured, an equally low score on both role limitations due to
physical health and role limitations due to emotional problems is found. To
help patients physical functioning there exist several medical devices, such as
orthopedic shoes, shoe lifts and walking aids. However, there is no mental
health care for the emotional problems associated with diabetic foot ulcer
Study objective
The aim of this study is to evaluate the effect of psychological intervention
on the quality of life and wound healing in patients with a foot ulcer.
Study design
A randomized, parallel group controlled trial
Intervention
A medical psychologist will perform 8 therapy sessions for 45 minutes once
every 2 weeks.
The therapy will include identifying and treatment of avoidance coping, coping
behavior therapy, lifestyle management and processing traumatic experiences.
After therapy, patients will complete the DFS-SF and SF-36 survey again.
Study burden and risks
Patients are asked to complete 2 questionnaires 3 times. In addition, once will
be asked to complete a short questionnaire on sociodemographic factors. The
patients in the intervention group are asked about wound healing status by
phone or at the hospital and to fill in the DFS-SF and SF-36 by phone, e-mail
or at the hospital after the psychological therapy has ended (+/- 2 months,
first follow-up moment) and 6 months (+/- 2 months) after the psychological
therapy has ended (second follow-up moment).
The patients in the control group are asked about wound healing status by phone
or at the hospital and to fill in the DFS-SF and SF-36 by phone, e-mail or at
the hospital at 6 months (+/- 2 months) after randomization (first follow-up
moment) and 12 months (+/- 2 months) after randomization (second follow-up
moment).
The 8 therapy sessions lasts 45 minutes and will take place once every 2 weeks
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Listed location countries
Age
Inclusion criteria
- Age 18-70 years
- Signed informed consent
- Diagnosed with diabetes mellitus
- * 1 neuropathic foot ulcer (toe pressure > 70 mmHg or the presence of
pulsatile foot arteries as checked by palpation) on or below the malleolus
- Able to read, write, speak and understand Dutch
- Attending outpatient diabetic foot clinic
- The foot ulcer exists > 6 weeks
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
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL66883.029.18 |
| OMON | NL-OMON27954 |