Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579326
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Photoacoustic Tomography in Assessment of Lower Extremity Artery Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multistructural Quantitative Photoacoustic Imaging of Human Feet With Lower Extremity Artery Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lower extremity artery disease LEAD is characterized by low awareness rate and high missed diagnosis rate leading to low treatment rate and high disabling mortality rate However none of the current examination methods can comprehensively and thoroughly evaluate the vascular structure and blood oxygen status of the lower extremity at the same time This study aims to evaluate the reliability and accuracy of photoacoustic tomography PACT in the diagnosis of lower limb arterial disease through a case-control study It is planned to recruit 30 patients with clinically confirmed LEAD 15 patients with stenosis 50 and 50 respectively and 5 patients without LEAD in preliminary clinical screening The reliability of PACT was assessed by repeated measurements within the observer and different inter-observer measurements of the same subject Compared with computed tomographic angiography CTA the sensitivity and specificity of PACT in diagnosing vascular stenosis were calculated The ability of PACT to determine tissue blood oxygen was assessed by comparing PACT functional imaging with ischemic grading as determined by ankle-brachial index ABI and transcutaneous oxygen pressure TcpO2 between subgroups
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None