Status:
COMPLETED
Important Parameters of NIR-II Imaging in the Early Diagnosis of Lower Extremity Peripheral Artery Disease
Lead Sponsor:
Yijie Ning
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18-85 years
Brief Summary
Lower extremity peripheral artery disease (PAD) is a growing global health problem. New ways have been explored to diagnose PAD in recent years, such as the second near-infrared region (NIR-II, 900-1,...
Detailed Description
1. The registry procedures and quality assurance: the study recruited patients diagnosed with type 2 diabetes from the Department of Endocrinology at the Second Hospital of Shanxi Medical University. ...
Eligibility Criteria
Inclusion
- The subjects are inpatients in the Department of Endocrinology, the Second Hospital of Shanxi Medical University.
- Male or female aged 18-85.
- Patients with type 2 diabetes (WHO 2019 diagnostic criteria).
- The subjects are conscious and fully aware of the research content. They sign the informed consent and agree to participate in the study.
Exclusion
- The patients who have been diagnosed with thyroid disease or are using other drugs that affect metabolism and cannot stop taking them.
- Indocyanine green or iodine allergy
- Previous history of lower limb revascularization surgery or lower limb amputation, or diabetic foot ulcers (current or past).
- Lymphedema, thrombophlebitis, deep vein thrombosis (current or past 6 months).
- Patients with acute infections, tumors, severe arrhythmias, psychiatric disorders, drug or alcohol addiction.
- NYHA grade Ⅱ - Ⅳ heart failure, liver function significantly abnormal or kidney function significantly abnormal
- Pregnant women, women planning pregnancy or breastfeeding.
- Participated in other clinical trials within 3 months prior to the trial.
- Refuse to sign informed consent and agree to participate in this study.
Key Trial Info
Start Date :
September 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06565819
Start Date
September 15 2024
End Date
December 30 2024
Last Update
March 19 2025
Active Locations (1)
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1
Full Spectrum Opening in Vivo Fluorescence Imaging System (DPM-IVFM-NIR-OF, Beijing Digital Precision Medicine Technology Co., Ltd., China)
Taiyuan, Shanxi, China, 030000