The effect of psychological intervention on the quality of life and wound healing in patients with diabetic foot ulcer
- Conditions
- diabetic foot ulcerfoot wound1004704310003216
- Registration Number
- NL-OMON49780
- Lead Sponsor
- oordwest Ziekenhuisgroep
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 42
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the score on the Short form 36 (SF-36) measured at the<br /><br>second follow-up moment (6 months (+/- 2 months) after therapy for the<br /><br>intervention group and 12 months (+/- 2 months) after randomization for the<br /><br>control group).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are:<br /><br>1. SF-36 results at the first follow up moment (at the end of therapy for the<br /><br>intervention group and 6 months after randomization for the control group)<br /><br>2. Diabetic Foot Ulcer scale short form (DFS-SF) results at the first follow-up<br /><br>moment.<br /><br>3. DFS-SF results at the second follow-up moment.<br /><br>4. Occurrence of wound healing at the second follow-up moment.<br /><br>5. minor amputation rate<br /><br>6. major amputation rate</p><br>