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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Full Spectrum Opening in Vivo Fluorescence Imaging System (DPM-IVFM-NIR-OF, Beijing Digital Precision Medicine Technology Co., Ltd., China)

Taiyuan, Shanxi, China, 030000