The effectiveness of using plantar pressure assessment and monitoring in prescription footwear to reduce re-ulceration rate in diabetic patients: A Randomized Controlled Trial.
Recruiting
- Conditions
- 1. Diabetes<br />2. Diabetic foot<br />3. Neuropathy<br />4. Footwear<br />5. Plantar pressure.
- Registration Number
- NL-OMON22571
- Lead Sponsor
- Academic Medical Center, Amsterdam, the Netherlands.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 240
Inclusion Criteria
1. Age >18 and <85 years old;
2. Diabetes mellitus type 1 or 2;
Exclusion Criteria
1. Active foot ulceration;
2. Amputation proximal to the metatarsal bones;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with a plantar diabetic foot ulcer within an 18-month follow-up period.
- Secondary Outcome Measures
Name Time Method 1. In-shoe peak plantar pressures;<br /> <br>2. Barefoot peak plantar pressures;<br /> <br>3. Cost-effectiveness and cost-utility;<br /><br>4. Perceived footwear usability;<br /> <br>5. Footwear use (adherence);<br /><br>6. Number of steps made per day (daily activity level).