NCT06565819Completed
Important Parameters of NIR-II Imaging in the Early Diagnosis of Lower Extremity Peripheral Artery Disease
A Trial of Important Parameters of NIR-II Imaging in the Diagnosis of Lower Extremity Peripheral Artery Disease in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 19 Mar 2025
Brief summary (registry, in English)
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, 900-1,880 nm wavelengths) imaging. In this study, NIR-II imaging was performed on patients with type 2 diabetes without PAD, and time-intensity curves were generated according to the imaging results, and specific parameters on the curves were analyzed. The key parameters for the diagnosis of lower limb artery plaque were obtained by comparing the parameters of patients with and without plaque. Patients will be followed up six months and one year after the first NIR-II imaging. The patient will undergo Duplex ultrasound (DUS), NIR-II imaging and laboratory examination. With DUS results as the reference standard, patients diagnosed with PAD for the first time during follow-up were focused on, and the parameter range of the first NIR-II imaging was statistically analyzed, so as to obtain the diagnostic threshold for early diagnosis of PAD.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 120 (actual)
- First submitted
- 14 Aug 2024
- Start date
- 15 Sept 2024
- Primary completion date
- 30 Dec 2024
- Lead sponsor
- Yijie Ning
- Diseases
- Type 2 diabetes
- NCT number
- NCT06565819
What you commit to
- Study type: Observational
- Participants enrolled: 120
- From 15 Sept 2024 to the primary completion date, 30 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of lower limb revascularization surgery or lower limb amputation, or diabetic foot ulcers (current or past).
- Participated in other clinical trials within 3 months prior to the trial.
Other illness
- 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
- 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
Other
- Pregnant women, women planning pregnancy or breastfeeding.
- Refuse to sign informed consent and agree to participate in this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Full Spectrum Opening in Vivo Fluorescence Imaging System (DPM-IVFM-NIR-OF, Beijing Digital Precision Medicine Technology Co., Ltd., China) Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.