Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2018-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Peripheral Vascular Disease in Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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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" .

Group Type OTHER

Five points test of Tongji university

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No