Important Parameters of NIR-II Imaging in the Early Diagnosis of Lower Extremity Peripheral Artery Disease
- Conditions
- Peripheral Artery Disease
- Registration Number
- NCT06565819
- Lead Sponsor
- Yijie Ning
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. The subjects are inpatients in the Department of Endocrinology, the Second Hospital<br> of Shanxi Medical University.<br><br> 2. Male or female aged 18-85.<br><br> 3. Patients with type 2 diabetes (WHO 2019 diagnostic criteria).<br><br> 4. The subjects are conscious and fully aware of the research content. They sign the<br> informed consent and agree to participate in the study.<br><br>Exclusion Criteria:<br><br> 1. The patients who have been diagnosed with thyroid disease or are using other drugs<br> that affect metabolism and cannot stop taking them.<br><br> 2. Indocyanine green or iodine allergy<br><br> 3. Previous history of lower limb revascularization surgery or lower limb amputation,<br> or diabetic foot ulcers (current or past).<br><br> 4. Lymphedema, thrombophlebitis, deep vein thrombosis (current or past 6 months).<br><br> 5. Patients with acute infections, tumors, severe arrhythmias, psychiatric disorders,<br> drug or alcohol addiction.<br><br> 6. NYHA grade ? - ? heart failure, liver function significantly abnormal or kidney<br> function significantly abnormal<br><br> 7. Pregnant women, women planning pregnancy or breastfeeding.<br><br> 8. Participated in other clinical trials within 3 months prior to the trial.<br><br> 9. Refuse to sign informed consent and agree to participate in this study.
Not provided
Study & Design
- Study Type
- Observational [Patient Registry]
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time related NIR-II parameters for patients newly diagnosed with PAD during follow-up (parameters at first imaging and follow-up imaging);Intensity related NIR-II parameters for patients newly diagnosed with PAD during follow-up (parameters at first imaging and follow-up imaging);Time-intensity related NIR-II parameters for patients newly diagnosed with PAD during follow-up (parameters at first imaging and follow-up imaging)
- Secondary Outcome Measures
Name Time Method