A study for performance verification of the scale for monitoring of diabetic complications
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0006093
- Lead Sponsor
- Korea University Ansan Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
? Subject inclusion criteria (patients with diabetes)
•Diabetes: Patients with type 2 diabetes aged 40 to 85 years who visited Korea University Ansan Hospital
•Criteria for neuropathy: Those who fall under any of the following criteria
- Those who have been diagnosed with diabetic neuropathy
- Those who are taking medications for diabetic neuropathy
- Those who had findings of diabetic neuropathy on the nerve conduction test conducted at the hospital
• Criteria for peripheral vascular disease: Those who fall under any of the following criteria
- Those who have been diagnosed with peripheral vascular disease
- Those whose results of ankle-brachial index testing conducted at the hospital are less than 1.0
- Those who are taking medications for peripheral vascular disease or have had a procedure or surgery for peripheral vascular disease
? Subject inclusion criteria (non-diabetic patients)
•Adults aged 40 to 85 years who do not have diabetes and do not fall under the criteria for neuropathy or peripheral vascular disease above
•Exclusion criteria are the same as those for patients with diabetics
• Type 1 diabetes
• Those with lower extremity deformity or a history of lower extremity amputation
• Lower extremity fractures or lower extremity surgery within last 3 months
• Excessive sweating of the feet
• Those who are determined to be not eligible for this study (Pregnant women, severe systemic diseases, mental illness, etc.)
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in foot heat distribution analyzed by the scale for monitoring of diabetic complications” between Group 1 and Group 2, 3, and 4
- Secondary Outcome Measures
Name Time Method Difference in foot pressure distribution analyzed by the scale for monitoring of diabetic complications” between Group 1 and Group 2, 3, and 4;Difference in foot heat and pressure distributions analyzed by the scale for monitoring of diabetic complications” between Group 0 and Group 1;Comparison of foot heat distributions measured by the scale for monitoring of diabetic complications” and a non-contact infrared thermometer