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Clinical Trial Summary

Microcirculation should be assessed before and after tibial bypass surgery by intraoperative fluorescence angiography. According to this, the direct and the indirect angiosomes should be compared according to the individual microcirculatory improvement.


Clinical Trial Description

Only patients at CLI stage Rutherford IV to VI with the necessity of tibial Bypass surgery will be included. Macrocirculation is measured by the ankle-brachial index (ABI). In order to assess the skin microcirculation intraoperative fluorescence angiography is used (SPY Elite™, NOVADAQ, Canada). The alteration of microcirculation is compared in direct and indirect revascularized angiosomes by calculation of the fluorescence parameters Ingress (IN) and Ingress rate (InR). Clinical Follow-up investigations will be performed and the wound healing rate is compared between the different revascularization methods. ;


Study Design

Intervention Model: Single Group Assignment, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT03012750
Study type Interventional
Source University Hospital Erlangen
Contact
Status Completed
Phase Phase 2
Start date February 2015
Completion date October 2016

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