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Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes

Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03528811
Enrollment
300
Registered
2018-05-18
Start date
2016-08-01
Completion date
2018-07-31
Last updated
2018-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Vascular Disease in Diabetes

Keywords

Diabetes, Peripheral Vascular Disease, Microcirculation

Brief summary

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

Interventions

DIAGNOSTIC_TESTFive 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.

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Coincidence rate of 5 points test of Tongji university12 monthsThe 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).

Countries

China

Contacts

Primary ContactMaoquan Li, Ph.D
cjr.limaoquan@vip.163.com02166313506

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026