Angiosome Perfusion After Tibial Bypass
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 3, 2017
CompletedFirst Posted
Study publicly available on registry
January 6, 2017
CompletedJanuary 6, 2017
January 1, 2017
1.5 years
January 3, 2017
January 4, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (1)
Correlation of the wound healing rates with indirect and direct revascularization
12 months
Study Arms (1)
foot perfusion
EXPERIMENTALintravenous application of indocyanine green in patients receiving tibial Bypass surgery
Interventions
Eligibility Criteria
You may qualify if:
- Patients at CLI Rutherford stages IV to VI
- Patients with necessity of tibial Bypass surgery
You may not qualify if:
- Allergy against indocyanine green
- Iodine allergy
- Contrast allergy
- Penicillin allergy
- Allergic diathesis
- Liver insufficiency
- Pregnancy
- Hyperthyreosis
- Pulmonary arterial hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29305093DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med. Ulrich Rother, Principal Investigator
Study Record Dates
First Submitted
January 3, 2017
First Posted
January 6, 2017
Study Start
February 1, 2015
Primary Completion
August 1, 2016
Study Completion
October 1, 2016
Last Updated
January 6, 2017
Record last verified: 2017-01