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Completed

NCT Number: NCT03012750

Angiosome Perfusion After Tibial Bypass

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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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indocyanine green

Drug

Perioperative application of 0.1 mg ICG per kg Body weight

Primary outcomes

  1. Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingress)

    Time frame: 12 months

    Comparison of the fluorescence parameter Ingress in the direct and indirect revascularized angiosome before and after tibial bypass surgery

  2. Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingressrate)

    Time frame: 12 months

    Comparison of the fluorescence parameter Ingressrate in the direct and indirect revascularized angiosome before and after tibial bypass surgery

Secondary outcomes

  1. Correlation of the wound healing rates with indirect and direct revascularization

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University Hospital Erlangen

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 6, 2017
Registry last updated
Jan 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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