Angiosome Perfusion After Tibial Bypass

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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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

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Peripheral Arterial Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Study Groups

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foot perfusion

intravenous application of indocyanine green in patients receiving tibial Bypass surgery

Group Type EXPERIMENTAL

Indocyanine Green

Intervention Type DRUG

Perioperative application of 0.1 mg ICG per kg Body weight

Interventions

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Indocyanine Green

Perioperative application of 0.1 mg ICG per kg Body weight

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No