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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03012750
Other study ID # SPY-Angiosome
Secondary ID
Status Completed
Phase Phase 2
First received January 3, 2017
Last updated January 4, 2017
Start date February 2015
Est. completion date October 2016

Study information

Verified date January 2017
Source University Hospital Erlangen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 99 Years
Eligibility 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

Intervention Model: Single Group Assignment, Primary Purpose: Diagnostic


Intervention

Drug:
Indocyanine Green
Perioperative application of 0.1 mg ICG per kg Body weight

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Erlangen

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 months No
Primary 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 12 months No
Secondary Correlation of the wound healing rates with indirect and direct revascularization 12 months No
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