NCT03012750

Angiosome Perfusion After Tibial Bypass

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Hospital Erlangen · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	Indocyanine Green	Perioperative application of 0.1 mg ICG per kg Body weight

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-08-01
• Completion: 2016-10-01
• First posted: 2017-01-06
• Last updated: 2017-01-06