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Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528811
Recruitment Status : Unknown
Verified May 2018 by Maoquan Li, Shanghai 10th People's Hospital.
Recruitment status was:  Recruiting
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Maoquan Li, Shanghai 10th People's Hospital

Tracking Information
First Submitted Date  ICMJE May 6, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date May 18, 2018
Actual Study Start Date  ICMJE August 1, 2016
Estimated Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2018)
Coincidence rate of "5 points test of Tongji university" [ Time Frame: 12 months ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes
Official Title  ICMJE Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes
Brief Summary The main aim of the present study was to evaluate the microcirculation of peripheral vascular disease in diabetes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE Peripheral Vascular Disease in Diabetes
Intervention  ICMJE Diagnostic Test: Five points test of Tongji university
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.
Study Arms  ICMJE Five points test of Tongji university
We established the evaluatation and follow-up system of diabetes vascular disease based on the method called "Five points test of Tongji university" .
Intervention: Diagnostic Test: Five points test of Tongji university
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 6, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2018
Estimated Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03528811
Other Study ID Numbers  ICMJE 4250085-34
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maoquan Li, Shanghai 10th People's Hospital
Study Sponsor  ICMJE Shanghai 10th People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Xue Li, Ph.D Shanghai 10th People's Hospital
PRS Account Shanghai 10th People's Hospital
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP