search
Back to results

Angiosome Perfusion After Tibial Bypass

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Indocyanine Green
Sponsored by
University Hospital Erlangen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    foot perfusion

    Arm Description

    intravenous application of indocyanine green in patients receiving tibial Bypass surgery

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Correlation of the wound healing rates with indirect and direct revascularization

    Full Information

    First Posted
    January 3, 2017
    Last Updated
    January 4, 2017
    Sponsor
    University Hospital Erlangen
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03012750
    Brief Title
    Angiosome Perfusion After Tibial Bypass
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    October 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital Erlangen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Arterial Disease

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Allocation
    N/A
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    foot perfusion
    Arm Type
    Experimental
    Arm Description
    intravenous application of indocyanine green in patients receiving tibial Bypass surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Indocyanine Green
    Intervention Description
    Perioperative application of 0.1 mg ICG per kg Body weight
    Primary Outcome Measure Information:
    Title
    Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingress)
    Description
    Comparison of the fluorescence parameter Ingress in the direct and indirect revascularized angiosome before and after tibial bypass surgery
    Time Frame
    12 months
    Title
    Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingressrate)
    Description
    Comparison of the fluorescence parameter Ingressrate in the direct and indirect revascularized angiosome before and after tibial bypass surgery
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Correlation of the wound healing rates with indirect and direct revascularization
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29305093
    Citation
    Rother U, Lang W, Horch RE, Ludolph I, Meyer A, Gefeller O, Regus S. Pilot Assessment of the Angiosome Concept by Intra-operative Fluorescence Angiography After Tibial Bypass Surgery. Eur J Vasc Endovasc Surg. 2018 Feb;55(2):215-221. doi: 10.1016/j.ejvs.2017.11.024. Epub 2018 Jan 3.
    Results Reference
    derived

    Learn more about this trial

    Angiosome Perfusion After Tibial Bypass

    We'll reach out to this number within 24 hrs