Angiosome Perfusion After Tibial Bypass

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03012750

Enrollment

Registered

2017-01-06

Start date

2015-02-28

Completion date

2016-10-31

Last updated

2017-01-06

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

Conditions

Peripheral Arterial Disease

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.

Interventions

DRUGIndocyanine Green

Perioperative application of 0.1 mg ICG per kg Body weight

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Correlation of the wound healing rates with indirect and direct revascularization	12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026