Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes

T

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

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

Trial contacts and locations

1

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Central trial contact

Maoquan Li, Ph.D

Data sourced from clinicaltrials.gov

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