- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03012750
Angiosome Perfusion After Tibial Bypass
January 4, 2017 updated by: Ulrich Rother, University Hospital Erlangen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: foot perfusion
intravenous application of indocyanine green in patients receiving tibial Bypass surgery
|
Perioperative application of 0.1 mg ICG per kg Body weight
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation of the wound healing rates with indirect and direct revascularization
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
January 3, 2017
First Submitted That Met QC Criteria
January 4, 2017
First Posted (Estimate)
January 6, 2017
Study Record Updates
Last Update Posted (Estimate)
January 6, 2017
Last Update Submitted That Met QC Criteria
January 4, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPY-Angiosome
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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