Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-02-20 @ 11:45 AM
Study NCT ID:
NCT03012750
Status:
COMPLETED
Last Update Posted:
2017-01-06
First Post:
2017-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Angiosome Perfusion After Tibial Bypass
Sponsor:
University Hospital Erlangen
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: