Angiosome Perfusion After Tibial Bypass

Phase 2

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Drug: Indocyanine Green

• Registration Number: NCT03012750
• Lead Sponsor: University Hospital Erlangen

Brief 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.

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2016-08
• Study Completion: 2016-10
• Status Verified: 2017-01
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-04
• Last Update Submitted: 2017-01-04
• Study First Posted: 2017-01-06
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients at CLI Rutherford stages IV to VI
• Patients with necessity of tibial Bypass surgery

Exclusion Criteria

• Allergy against indocyanine green
• Iodine allergy
• Contrast allergy
• Penicillin allergy
• Allergic diathesis
• Liver insufficiency
• Pregnancy
• Hyperthyreosis
• Pulmonary arterial hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
foot perfusion	Indocyanine Green	intravenous application of indocyanine green in patients receiving tibial Bypass surgery

Primary Outcome Measures

Name	Time	Method
Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingress)	12 months	Comparison of the fluorescence parameter Ingress in the direct and indirect revascularized angiosome before and after tibial bypass surgery
Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingressrate)	12 months	Comparison of the fluorescence parameter Ingressrate in the direct and indirect revascularized angiosome before and after tibial bypass surgery

Secondary Outcome Measures

Name	Time	Method
Correlation of the wound healing rates with indirect and direct revascularization	12 months