Critical Limb IschemiaPOP-CLINCT05575778
Peri-operative Foot CT Perfusion in CLI Patients
An observational study of Critical Limb Ischemia, run by Fudan University at 1 site in China.
Trial summary
To investigate the clinical value of quantitative analysis of peri-operative foot supply through CT perfusion in patients with critical limb ischemia Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- computed tomographic perfusion
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Jun 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with critical limb ischemia, who completed both pre- and post-operative CTP workups
Who may be able to join
- 18 to 80 years old;
- CLI patients with Fontaine grade III-IV or Rutherford grade 4-6 and underwent a successful revascularization;
- Patients completed both pre- and post-operative CTP workups;
- Patients signed the informed consent form and be able to complete the clinical follow-up for 12 months.
Who cannot join
- Patients has participated in other clinical studies;
- Patients with Heart failure (NYHA III/IV)/right to left shunt heart disease/severe aortic and mitral insufficiency/acute coronary syndrome/malignant arrhythmia/severe pulmonary hypertension (pulmonary artery pressure at least 90 mmHg)/moderate to severe renal insufficiency (creatinine clearance rate<60 ml/min)
- Any allergic constitution;
- Pregnancy and childbirth;
- Life expectancy<12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Value of Quantitative Analysis of Peri-operative Foot Supply Through CT Perfusion in Patients With Critical Limb Ischemia
To investigate the clinical value of quantitative analysis of peri-operative foot supply through CT perfusion in patients with critical limb ischemia
- Conditions
- Critical Limb Ischemia
- Being tested
- computed tomographic perfusion
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomographic perfusionDiagnostic test
The recruited patients would complete both pre- and post-operative computed tomographic perfusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative computed tomographic perfusion parameters
Pre-operative computed tomographic perfusion parameters, including peak intensity, time to peak, and etc, which would be obtained three days before revascularization.
Measured: 18months
Post-operative computed tomographic perfusion parameters
Post-operative computed tomographic perfusion parameters, including peak intensity, time to peak, and etc, which would be obtained three days ater revascularization.
Measured: 18months
Alteration of computed tomographic perfusion parameters
Alteration between post- (three days ater revascularization) and pre-operative (three days before revascularization) computed tomographic perfusion parameters
Measured: 18months
Secondary outcomes (2)
Major adverse limb events
Major adverse limb events included major amputation or acute limb ishchemia for vasular causes.
Measured: 12months
Major adverse cardiovascular events
Major adverse cardiovascular events included myocardial infarction, ischemic stroke, or death from cadiovascular causes.
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Oct 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
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 Critical Limb IschemiaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
- Investigators
- Wan Zhang, PH.D., Principal investigator, Huadong Hospital affiliated to Fudan University, Shanghai, China, 200040
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575778
- Sponsor's protocol ID
- 2022KW
- Acronym
- POP-CLI
- Status last verified
- Aug 2026
- First submitted
- 5 Oct 2022
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Du S, Gao P, Zhou K, Zhang J, Zhu T, Zhang W. Quantitative assessment of foot microcirculation by CT perfusion differentiates chronic limb-threatening ischemia from claudication in peripheral artery disease. Vasc Med. 2026 Oct 17:1358863X261470372. doi: 10.1177/1358863X261470372. Online ahead of print.
PubMed 42891972
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Value of Quantitative Analysis of Peri-operative Foot Supply Through CT Perfusion in Patients With Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT05575778
- Acronym / sponsor ID
- POP-CLI / 2022KW
- Conditions
- Critical Limb Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 12 Oct 2022 (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.
To investigate the clinical value of quantitative analysis of peri-operative foot supply through CT perfusion in patients with critical limb ischemia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with critical limb ischemia, who completed both pre- and post-operative CTP workups
Key inclusion criteria (4 listed)
- 18 to 80 years old;
- CLI patients with Fontaine grade III-IV or Rutherford grade 4-6 and underwent a successful revascularization;
- Patients completed both pre- and post-operative CTP workups;
- Patients signed the informed consent form and be able to complete the clinical follow-up for 12 months.
Key exclusion criteria (5 listed)
- Patients has participated in other clinical studies;
- Patients with Heart failure (NYHA III/IV)/right to left shunt heart disease/severe aortic and mitral insufficiency/acute coronary syndrome/malignant arrhythmia/severe pulmonary hypertension (pulmonary artery pressure at least 90 mmHg)/moderate to severe renal insufficiency (creatinine clearance rate<60 ml/min)
- Any allergic constitution;
- Pregnancy and childbirth;
- Life expectancy<12 months.
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 |
|---|---|---|
| computed tomographic perfusionThe recruited patients would complete both pre- and post-operative computed tomographic perfusion | Diagnostic test | – |
Primary outcome
Pre-operative computed tomographic perfusion parameters
Time frame: 18months
Pre-operative computed tomographic perfusion parameters, including peak intensity, time to peak, and etc, which would be obtained three days before revascularization.
Post-operative computed tomographic perfusion parameters
Time frame: 18months
Post-operative computed tomographic perfusion parameters, including peak intensity, time to peak, and etc, which would be obtained three days ater revascularization.
Alteration of computed tomographic perfusion parameters
Time frame: 18months
Alteration between post- (three days ater revascularization) and pre-operative (three days before revascularization) computed tomographic perfusion parameters
2 secondary outcomes
Major adverse limb events
Time frame: 12months
Major adverse cardiovascular events
Time frame: 12months
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 2 Sep 2026.
- Derived from this study: PubMed 42891972Du S, Gao P, Zhou K, Zhang J, Zhu T, Zhang W. Quantitative assessment of foot microcirculation by CT perfusion differentiates chronic limb-threatening ischemia from claudication in peripheral artery disease. Vasc Med. 2026 Oct 17:1358863X261470372. doi: 10.1177/1358863X261470372. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Wan Zhang, PH.D. principal investigator
Huadong Hospital affiliated to Fudan University, Shanghai, China, 200040
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 Critical Limb Ischemia, run by Fudan University 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 5 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 2 Sep 2026. 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?
Pre-operative computed tomographic perfusion parameters (time frame: 18months). 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 NCT05575778, 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 2 Sep 2026.