Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes

Tongji University

Status and phase: Unknown; Phase 1

Conditions: Peripheral Vascular Disease in Diabetes

Treatments: Diagnostic Test: Five points test of Tongji university

Study type: Interventional

Funder types: Other

Identifiers

NCT03528811

4250085-34

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 1 patient group

Five points test of Tongji university

Other group

Description:

We established the evaluatation and follow-up system of diabetes vascular disease based on the method called "Five points test of Tongji university" .

Treatment:

Diagnostic Test: Five points test of Tongji university