Peripheral Artery DiseaseNCT06565819
Important Parameters of NIR-II Imaging in the Early Diagnosis of Lower Extremity Peripheral Artery Disease
An observational study of Peripheral Artery Disease, run by Yijie Ning at 1 site in China.
Trial 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, 900-1,880 nm wavelengths) imaging. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- The second near-infrared region (NIR-II) imaging for lower extremity peripheral artery disease (PAD)
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2024to 30 Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population were inpatients with type 2 diabetes from the Department of Endocrinology, the Second Hospital of Shanxi Medical University.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Full Spectrum Opening in Vivo Fluorescence Imaging System (DPM-IVFM-NIR-OF, Beijing Digital Precision Medicine Technology Co., Ltd., China)
Taiyuan, Shanxi, 030000
About this study
Official title: A Trial of Important Parameters of NIR-II Imaging in the Diagnosis of Lower Extremity Peripheral Artery Disease in Patients With Type 2 Diabetes
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.
Read the detailed description
- 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. If the patient meets the inclusion criteria and agrees to be enrolled, a written informed consent will be signed. The imaging process is completed by a uniform standard, and all imaging operations are performed by the same operator. The operator has been formally trained and the procedure and results are checked by another professional NIR imaging engineer.
- Imaging process: The imaging device used was Full Spectrum Opening in Vivo Fluorescence Imaging System (DPM-IVFM-NIR-OF, Beijing Digital Precision Medicine Technology Co., Ltd., China). Firstly, participants were asked if they had a history of indocyanine green (ICG) or iodine allergy. If there was no relevant allergy history, an ICG skin test was performed on each participant. The skin test reagent was the ICG solution (Dandong Yichuang Pharmaceutical, China) with a concentration of 0.005mg/mL (diluted with sterile water for injection) . The test reagent (0.1 ml) was injected subcutaneously into the inner forearm and the subject was observed for 20 min. If there was no allergic reaction, an indent needle was placed in the basilic vein of patients. The NIR imaging was conducted in a room without natural light. Before the examination, the subject rested for at least 15 min in a supine position with both knee joints bent 90 degrees and both feet put together, and then step horizontally on the black background board on the examination bed. In NIR-II imaging, the selected filter was 1000 nm long-pass. The power of the 808nm wavelength laser emitter was adjusted to 10000mW with the aperture size adjusted to 2.0 and the exposure time set to 100 ms. The laser emitter was fixed at 20cm vertical to the dorsal foot, and the NIR-II camera was fixed at 40cm vertical to the dorsal foot. ICG solution (2.5 mg/mL, diluted with sterile water for injection) was administered intravenously via an indignant needle. The dose of ICG injected was determined according to body weight: 0.1mg/Kg. The time for intravenous injection of ICG solution was 5 seconds. The intensity of fluorescence signal on both the dorsal feet was recorded within 5 minutes after ICG solution was injected. The dorsal pedis region from the transverse tarsus joint to the distal metatarsal bone was selected as the region of interest (ROI). The ROI was analyzed using the built-in analysis software External Data processing to generate a time-intensity curve.
- Plan for missing data: missing data will be excluded from analysis.
- Methods to summarize the data: NIR-II parameters extracted from time-intensity curves for all patients were recorded in the same excell table. In addition, baseline information (such as age, gender, height, weight, etc.) and clinical characteristics (such as years of diabetes, hypertension, hyperlipidemia, etc.) of all patients were recorded in this table.
- Statistical analysis: In this study, SPSS 26.0 software and R 4.2.0 software were used to conduct in-depth statistical research. When processing measurement data, the Kolmogorov-Smirnov test was first used to verify whether the data followed the normal distribution. Data with a normal distribution was represented by x±s, while data with a skewed distribution was represented by M (Q1, Q3). For comparison between groups, the independent sample test or the Mann-Whitney U test were selected. For classified data, χ2 test or Fisher exact probability method was chosen for further investigation. A significance level of P < 0.05 means that the difference was statistically significant.
- Conditions
- Peripheral Artery Disease
- Being tested
- The second near-infrared region (NIR-II) imaging for lower extremity peripheral artery disease (PAD)
- Keywords
- Peripheral artery disease, Second near-infrared region imaging
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The second near-infrared region (NIR-II) imaging for lower extremity peripheral artery disease (PAD)Diagnostic test
Also called Duplex ultrasound (DUS)
DUS was used as reference criteria to screen out patients newly diagnosed with PAD during follow-up. In this study, NIR-II imaging results of patients at follow-up and initial examination were collected to obtain a threshold for early diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 2 diabetes who had not been diagnosed with lower peripheral artery disease | Patients received NIR-II and DUS six months and one year after the first NIR-II examination Receives: Diagnostic Test: The second near-infrared region (NIR-II) imaging for lower extremity peripheral artery disease (PAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time related NIR-II parameters for patients newly diagnosed with PAD during follow-up (parameters at first imaging and follow-up imaging)
In this study, 5-minute NIR-II imaging video of each patient was processed into time-intensity curves to quantify the imaging results. Four time related parameters on time-intensity curves were extracted, including：T start (s), Tmax (s), T 1/2 (s), TR (Time ratio).
Note: "s" is used as the unit "second".
Measured: Baseline, 6 months and 1year
Intensity related NIR-II parameters for patients newly diagnosed with PAD during follow-up (parameters at first imaging and follow-up imaging)
In this study, 5-minute NIR-II imaging video of each patient was processed into time-intensity curves to quantify the imaging results. Three intensity related parameters on time-intensity curves were extracted, including：Imax (Fi), Ingress (Fi), Engress (Fi).
Note: "Fi" is used as the unit "fluorescence intensity".
Measured: Baseline, 6 months and 1year
Time-intensity related NIR-II parameters for patients newly diagnosed with PAD during follow-up (parameters at first imaging and follow-up imaging)
In this study, 5-minute NIR-II imaging video of each patient was processed into time-intensity curves to quantify the imaging results. Two time-intensity related parameters on time-intensity curves were extracted, including：Ingress rate (Fi/s), Engress rate (Fi/s).
Note: "s" is used as the unit "second" and "Fi" is used as the unit "fluorescence intensity".
Measured: Baseline, 6 months and 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start15 Sep 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Yijie Ning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yijie Ning, Second Hospital of Shanxi Medical University
- Investigators
- Ruijing Zhang, Doctoral degree, Study director, Second Hospital of Shanxi Medical UniversityHonglin Dong, Doctoral degree, Study chair, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565819
- Sponsor's protocol ID
- [2024]YX211
- Status last verified
- Mar 2025
- First submitted
- 14 Aug 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient baseline data and statistical methods will be shared
Publications
van den Hoven P, Ooms S, van Manen L, van der Bogt KEA, van Schaik J, Hamming JF, Vahrmeijer AL, van der Vorst JR, Mieog JSD. A systematic review of the use of near-infrared fluorescence imaging in patients with peripheral artery disease. J Vasc Surg. 2019 Jul;70(1):286-297.e1. doi: 10.1016/j.jvs.2018.11.023.
PubMed 31230648
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Important Parameters of NIR-II Imaging in the Diagnosis of Lower Extremity Peripheral Artery Disease in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06565819
- Acronym / sponsor ID
- [2024]YX211
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral artery disease, Second near-infrared region imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yijie NingUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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. If the patient meets the inclusion criteria and agrees to be enrolled, a written informed consent will be signed. The imaging process is completed by a uniform standard, and all imaging operations are performed by the same operator. The operator has been formally trained and the procedure and results are checked by another professional NIR imaging engineer.
- Imaging process: The imaging device used was Full Spectrum Opening in Vivo Fluorescence Imaging System (DPM-IVFM-NIR-OF, Beijing Digital Precision Medicine Technology Co., Ltd., China). Firstly, participants were asked if they had a history of indocyanine green (ICG) or iodine allergy. If there was no relevant allergy history, an ICG skin test was performed on each participant. The skin test reagent was the ICG solution (Dandong Yichuang Pharmaceutical, China) with a concentration of 0.005mg/mL (diluted with sterile water for injection) . The test reagent (0.1 ml) was injected subcutaneously into the inner forearm and the subject was observed for 20 min. If there was no allergic reaction, an indent needle was placed in the basilic vein of patients. The NIR imaging was conducted in a room without natural light. Before the examination, the subject rested for at least 15 min in a supine position with both knee joints bent 90 degrees and both feet put together, and then step horizontally on the black background board on the examination bed. In NIR-II imaging, the selected filter was 1000 nm long-pass. The power of the 808nm wavelength laser emitter was adjusted to 10000mW with the aperture size adjusted to 2.0 and the exposure time set to 100 ms. The laser emitter was fixed at 20cm vertical to the dorsal foot, and the NIR-II camera was fixed at 40cm vertical to the dorsal foot. ICG solution (2.5 mg/mL, diluted with sterile water for injection) was administered intravenously via an indignant needle. The dose of ICG injected was determined according to body weight: 0.1mg/Kg. The time for intravenous injection of ICG solution was 5 seconds. The intensity of fluorescence signal on both the dorsal feet was recorded within 5 minutes after ICG solution was injected. The dorsal pedis region from the transverse tarsus joint to the distal metatarsal bone was selected as the region of interest (ROI). The ROI was analyzed using the built-in analysis software External Data processing to generate a time-intensity curve.
- Plan for missing data: missing data will be excluded from analysis.
- Methods to summarize the data: NIR-II parameters extracted from time-intensity curves for all patients were recorded in the same excell table. In addition, baseline information (such as age, gender, height, weight, etc.) and clinical characteristics (such as years of diabetes, hypertension, hyperlipidemia, etc.) of all patients were recorded in this table.
- Statistical analysis: In this study, SPSS 26.0 software and R 4.2.0 software were used to conduct in-depth statistical research. When processing measurement data, the Kolmogorov-Smirnov test was first used to verify whether the data followed the normal distribution. Data with a normal distribution was represented by x±s, while data with a skewed distribution was represented by M (Q1, Q3). For comparison between groups, the independent sample test or the Mann-Whitney U test were selected. For classified data, χ2 test or Fisher exact probability method was chosen for further investigation. A significance level of P < 0.05 means that the difference was statistically significant.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes who had not been diagnosed with lower peripheral artery disease | – | Diagnostic Test: The second near-infrared region (NIR-II) imaging for lower extremity peripheral artery disease (PAD)Patients received NIR-II and DUS six months and one year after the first NIR-II examination |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population were inpatients with type 2 diabetes from the Department of Endocrinology, the Second Hospital of Shanxi Medical University.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The second near-infrared region (NIR-II) imaging for lower extremity peripheral artery disease (PAD)Also: Duplex ultrasound (DUS)DUS was used as reference criteria to screen out patients newly diagnosed with PAD during follow-up. In this study, NIR-II imaging results of patients at follow-up and initial examination were collected to obtain a threshold for early diagnosis. | Diagnostic test | Patients with type 2 diabetes who had not been diagnosed with lower peripheral artery disease |
Primary outcome
Time related NIR-II parameters for patients newly diagnosed with PAD during follow-up (parameters at first imaging and follow-up imaging)
Time frame: Baseline, 6 months and 1year
In this study, 5-minute NIR-II imaging video of each patient was processed into time-intensity curves to quantify the imaging results. Four time related parameters on time-intensity curves were extracted, including：T start (s), Tmax (s), T 1/2 (s), TR (Time ratio). Note: "s" is used as the unit "second".
Intensity related NIR-II parameters for patients newly diagnosed with PAD during follow-up (parameters at first imaging and follow-up imaging)
Time frame: Baseline, 6 months and 1year
In this study, 5-minute NIR-II imaging video of each patient was processed into time-intensity curves to quantify the imaging results. Three intensity related parameters on time-intensity curves were extracted, including：Imax (Fi), Ingress (Fi), Engress (Fi). Note: "Fi" is used as the unit "fluorescence intensity".
Time-intensity related NIR-II parameters for patients newly diagnosed with PAD during follow-up (parameters at first imaging and follow-up imaging)
Time frame: Baseline, 6 months and 1year
In this study, 5-minute NIR-II imaging video of each patient was processed into time-intensity curves to quantify the imaging results. Two time-intensity related parameters on time-intensity curves were extracted, including：Ingress rate (Fi/s), Engress rate (Fi/s). Note: "s" is used as the unit "second" and "Fi" is used as the unit "fluorescence intensity".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Results publication: PubMed 31230648van den Hoven P, Ooms S, van Manen L, van der Bogt KEA, van Schaik J, Hamming JF, Vahrmeijer AL, van der Vorst JR, Mieog JSD. A systematic review of the use of near-infrared fluorescence imaging in patients with peripheral artery disease. J Vasc Surg. 2019 Jul;70(1):286-297.e1. doi: 10.1016/j.jvs.2018.11.023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient baseline data and statistical methods will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruijing Zhang, Doctoral degree study director
Second Hospital of Shanxi Medical University
Honglin Dong, Doctoral degree study chair
Second Hospital of Shanxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by Yijie Ning at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time related NIR-II parameters for patients newly diagnosed with PAD during follow-up (parameters at first imaging and follow-up imaging) (time frame: Baseline, 6 months and 1year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06565819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.