Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes

Phase 1

• Conditions: Peripheral Vascular Disease in Diabetes
• Interventions: Diagnostic Test: Five points test of Tongji university

• Registration Number: NCT03528811
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-01
• Status Verified: 2018-05
• Study First Submitted: 2018-05-06
• Study First Submitted QC: 2018-05-06
• Last Update Submitted: 2018-05-06
• Study First Posted: 2018-05-18
• Last Update Posted: 2018-05-18
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Five points test of Tongji university	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" .

Primary Outcome Measures

Name	Time	Method
Coincidence rate of "5 points test of Tongji university"	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).

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital, Tong ji University; 🇨🇳 Shanghai, China