Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes

May 6, 2018 updated by: Maoquan Li, Shanghai 10th People's Hospital
The main aim of the present study was to evaluate the microcirculation of peripheral vascular disease in diabetes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Tenth People's Hospital, Tong ji University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Investigators

  • Study Director: Xue Li, Ph.D, Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Anticipated)

July 31, 2018

Study Completion (Anticipated)

July 31, 2018

Study Registration Dates

First Submitted

May 6, 2018

First Submitted That Met QC Criteria

May 6, 2018

First Posted (Actual)

May 18, 2018

Study Record Updates

Last Update Posted (Actual)

May 18, 2018

Last Update Submitted That Met QC Criteria

May 6, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4250085-34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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