Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Brief Summary:
The main aim of the present study was to evaluate the microcirculation of peripheral vascular disease in diabetes.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease in Diabetes Diagnostic Test: Five points test of Tongji university Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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" .
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.




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528811


Contacts
Layout table for location contacts
Contact: Maoquan Li, Ph.D 02166313506 cjr.limaoquan@vip.163.com

Locations
Layout table for location information
China
Shanghai Tenth People's Hospital, Tong ji University Recruiting
Shanghai, China
Contact: Mao Q Li, Ph.D    02166313506    cjr.limaoquan@vip.163.com   
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
Layout table for investigator information
Study Director: Xue Li, Ph.D Shanghai 10th People's Hospital
Layout table for additonal information
Responsible Party: Maoquan Li, Chief Physician, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT03528811    
Other Study ID Numbers: 4250085-34
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Keywords provided by Maoquan Li, Shanghai 10th People's Hospital:
Diabetes
Peripheral Vascular Disease
Microcirculation
Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases