Ignite Creation Date:
2024-07-17 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485622
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-20
Brief Title:
Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans
Sponsor:
First Affiliated Hospital Sun Yat-Sen University
Organization:
First Affiliated Hospital Sun Yat-Sen University
Study Overview
Official Title:
Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans a Prospective Single-center Observational Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective single-center observational study In this study we aim to evaluate the clinical outcome and cost-effectiveness of different treatments of lower extremity arterial occlusive disease It is expected to include about 400 patients diagnosed with lower extremity arterial occlusive disease in our center from July 2024 to July 2026 All enrolled patients will be followed for three years All patients diagnosed with arteriosclerosis obliterans ASO and all treatment techniques were included in this study The primary outcomes include the Efficacy and Safety End Points of each techniques
Detailed Description:
Arteriosclerosis obliterans ASO is a kind of lower extremity arterial disease which occurs frequently in middle-aged and elderly people The incidence of ASO increases with age In patients with ASO the build-up of fatty deposits cholesterol and other substances plaques in the arteries reduces blood flow to the extremities This can lead to symptoms such as leg pain cramping and fatigue especially during physical activity In severe cases it may result in pain at rest non-healing wounds and complications such as tissue damage or infection Chronic wound is one of the symptoms that affect the quality of life Therefore wound healing is also an important index for postoperative care However no study has reported detailed performance data for different treatments As an auxiliary method in clinical treatment nutrition plays an important role in improving the clinical outcome of patients in the development and postoperative stages of the disease The effect of nutritional risk assessment and nutritional education on postoperative symptoms of ASO has not been reported Therefore we plan to carry out this prospective single-center observational study providing new data on the efficacy safety and cost-effectiveness for different treatment and assistive techniques in lower extremity arterial occlusive disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None