The cost-effectiveness and cost-utility of monitoring foot temperature at home to prevent foot ulcer recurrence in patients with diabetes
- Conditions
- Diabetes mellitus, diabetic foot, foot ulcer
- Registration Number
- NL-OMON25946
- Lead Sponsor
- Academic Medical Center (AMC), Amsterdam
- Brief Summary
one
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 304
Inclusion Criteria
1. Diabetes mellitus type 1 or 2;
2. Age 18 or above;
Exclusion Criteria
1. Active foot ulceration or open amputation site
2. Active Charcot neuro-osteo arthropathy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - The proportion of patients with a foot ulcer recurrence on the plantar foot or medial and lateral forefoot surface during 18 months follow-up <br /><br>- Cost (savings) per patient without a recurrent foot ulcer and per quality adjusted life year<br>
- Secondary Outcome Measures
Name Time Method - Costs of advanced therapy and ulcer treatment<br /><br>- Adherence to at-home temperature monitoring<br /><br>- In-shoe dynamic plantar pressure<br /><br>- Barefoot dynamic plantar pressure <br /><br>- Number of steps per day (daily ambulatory activity level)<br /><br>- Footwear use <br /><br>- Adverse events<br /><br>- Quality of life