Peripheral Arterial Disease Clinical Trial
Verified date | January 2017 |
Source | University Hospital Erlangen |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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.
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 |
Intervention Model: Single Group Assignment, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital Erlangen |
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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