Back to resultsEvaluation of Microcirculation of Peripheral Vascular Disease in Diabetes
Primary Purpose
Peripheral Vascular Disease in Diabetes
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Five points test of Tongji university
Sponsored by
About this trial
This is an interventional diagnostic trial for Peripheral Vascular Disease in Diabetes focused on measuring Diabetes, Peripheral Vascular Disease, Microcirculation
Eligibility Criteria
Inclusion Criteria:
1.Patients with Peripheral vascular disease with or without diabetes. 2.Rutherford class 2-6. 3.Target lesions with a diameter reduction of at least 50% on angiography, and without past history of any intervention.
4.Target vessel with 2.0--10.0mm in diameter and having a lesion of about 4cm-20cm in length.
5.Written informed consent signed by the patients or representatives
Exclusion Criteria:
- 1.Previous bypass surgery or stent placement at the ipsilateral lower limb 2.History of intolerance to antiplatelet therapy, heparin, or contrast media. 3.Bleeding diathesis; 4.Active systemic bacterial infection; 5.Severely impaired renal function (serum creatinine level > 2.5 mg/dL. Expected survival time of less than 24 months
Sites / Locations
- Shanghai Tenth People's Hospital, Tong ji UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Five points test of Tongji university
Arm Description
We established the evaluatation and follow-up system of diabetes vascular disease based on the method called "Five points test of Tongji university" .
Outcomes
Primary Outcome Measures
Coincidence rate of "5 points test of Tongji university"
The primary study endpoint was that the coincidence rate of evaluating the microcirculation by the newly-established "5 points test of Tongji university" attains over 95% before and after operations as assessed by digital substraction angiography (DSA).
Secondary Outcome Measures
Full Information
NCT ID
NCT03528811
First Posted
May 6, 2018
Last Updated
May 6, 2018
Sponsor
Shanghai 10th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03528811
Brief Title
Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes
Official Title
Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
July 31, 2018 (Anticipated)
Study Completion Date
July 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main aim of the present study was to evaluate the microcirculation of peripheral vascular disease in diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease in Diabetes
Keywords
Diabetes, Peripheral Vascular Disease, Microcirculation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Five points test of Tongji university
Arm Type
Other
Arm Description
We established the evaluatation and follow-up system of diabetes vascular disease based on the method called "Five points test of Tongji university" .
Intervention Type
Diagnostic Test
Intervention Name(s)
Five points test of Tongji university
Intervention Description
In each group, we will evaluate the microcirculation of diabetic foot using the newly-established "Five points test of Tongji university" before or after the operation, and then compare the temperature of the five points with the other data.
Primary Outcome Measure Information:
Title
Coincidence rate of "5 points test of Tongji university"
Description
The primary study endpoint was that the coincidence rate of evaluating the microcirculation by the newly-established "5 points test of Tongji university" attains over 95% before and after operations as assessed by digital substraction angiography (DSA).
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Patients with Peripheral vascular disease with or without diabetes. 2.Rutherford class 2-6. 3.Target lesions with a diameter reduction of at least 50% on angiography, and without past history of any intervention.
4.Target vessel with 2.0--10.0mm in diameter and having a lesion of about 4cm-20cm in length.
5.Written informed consent signed by the patients or representatives
Exclusion Criteria:
1.Previous bypass surgery or stent placement at the ipsilateral lower limb 2.History of intolerance to antiplatelet therapy, heparin, or contrast media. 3.Bleeding diathesis; 4.Active systemic bacterial infection; 5.Severely impaired renal function (serum creatinine level > 2.5 mg/dL. Expected survival time of less than 24 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maoquan Li, Ph.D
Phone
02166313506
Email
cjr.limaoquan@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xue Li, Ph.D
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Tenth People's Hospital, Tong ji University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mao Q Li, Ph.D
Phone
02166313506
Email
cjr.limaoquan@vip.163.com
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes
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