Objectives of the study are to evaluate the clinical applicability of the PeriFlux System 5000 and to investigate the reproducability of its measurements on inter- (and intra-observer) variability.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primairy endpoints of this study are differences in microcirculatory parameters
between the Doppler and TcPO2 measurements. In addition, the time needed to
perform the measurements will be used as a indicator for the burden for the
subject. Total time needed for measurements and analysis will be used as an
indicator for clinical applicability.
Secondary outcome
not applicable
Background summary
In the JUVENTAS Trial, patients with critical limb ischemia (CLI), who have no
surgical or radiological revascularisation options, are treated with stem cell
therapy. In order to evaluate the effects of stem cell therapy in these
patients, MRA, MR-perfusion, walking test and ABI measurement are performed. To
further evaluate the effects of stem cell therapy on a microcirculatory level,
a microcirculatory measurement system could be used. However, before such
system can be used in the Trial, its clinical applicability should be tested.
Combined Laser Doppler and transcuteanous oxygen pressure measurements can be
used to assess the effects of stem cell therapy on a microcirculatory level.
Moreover, by using provocations like local heating or breathing 100% oxygen,
the microcirculatory reserve capacity can be determined.
The PeriFlux System 5000 (PeriMed) allows for simultaneous and standardised way
of measuring microcirculatory parameters. Based on many publications of the
past 20 years, it is expected that combined laser Doppler and transcuteanous
oxygen pressure measurements, supplemented with above mentioned provocation
tests, can provide a reliable representation of the microcirculatory status and
reserve capacity in patients participating in the JUVENTAS Trial. However,
before the system can be used in the Trial, its clinical applicability should
be tested to minimize discomfort.
Study objective
Objectives of the study are to evaluate the clinical applicability of the
PeriFlux System 5000 and to investigate the reproducability of its measurements
on inter- (and intra-observer) variability.
Study design
In 10 patients who will receive a trombendarterectomy (TEA) or remote
endarterectomy of the iliaco-femoral vessels 2 measurements by 2 independent
investigators will be performed before and after surgery. By comparing the
measurements of the 2 investigators, inter-observer variability can be
determined. By comparing the pre- and post-surgical measurements, it can be
investigated if the intended microcirculatory perfusion improvement can be
measured with laser Doppler and TcpO2.
Study burden and risks
The burden for the subjects is considered minimal. The burden will consist of 2
measurements before surgery (measuring time 100 minutes) and 2 measurements
after surgery (also 100 minutes). The measurements are performed during regular
admission to the hospital and thus do not take additional time. The
measurements will be performed in a non-invasive way.
Postbus 85500
3508 GA Utrecht
Nederland
Postbus 85500
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
PAOD Fontaine II of the iliacofemoral vessels that will be treated with TEA
Exclusion criteria
Extensive PAOD Fontaine II of other (more distal) vessels
Bypass surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15971.041.07 |