Assess the predictive capabilities of LSCI on the effect of endovascular revascularization on the microcirculation of the feet over time and what could this mean for clinical decision-making.
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
LSCI (Perfusion Units) at specific regions or over time.
Oxygen (TcPO2) pressure in mmHg per measurement location and over time
Clinical outcome using multiple parameters derived from the patient files, such
as wound healing (time to), successful revascularization (based on DSA), ankle
brachial index, toe pressure, amputation yes/no, wound status (WiFi
classification) and VAS score
Secondary outcome
Objective 1,2 and 3, are needed to answer the main objective and therefore use
the same parameters. Objective 4 will use additional regions of interest
(measured in Perfusion Units) to determine the distribution of LSCI perfusion
units in the presence of an ulcer.
Background summary
In patients with chronic limb threatening ischemia (CLTI), often associated
with Diabetes Mellitus (DM), an insufficient blood supply will result in
ischemic restpain, or wounds that heal slowly or not at all. To enable wound
healing a revascularization procedure is needed, where an endovascular approach
is often the preferred treatment. Currently, there is no sufficient technique
to determine the severity of (local) ischemia. Laser speckle contrast imaging
is a technique that can image the microcirculation, measuring the superficial
blood flow in tissue and the wound, giving more insights into (local) ischemia.
Transcutaneous oxygen pressure (TcPO2) is a measurement to measure the
oxygenation status at a single point on the skin. Using this study, we want to
gain more insight in how and especially when both techniques can be used, so
that caretakers can act based on these measurements and prevent ulcers or even
amputations.
Study objective
Assess the predictive capabilities of LSCI on the effect of endovascular
revascularization on the microcirculation of the feet over time and what could
this mean for clinical decision-making.
Study design
Multicentre observational cohort study.
Study burden and risks
Measurements will be performed during regular appointments at the outpatient
clinic. Due to the non-invasive nature of this study, there is no burden or
risk associated with participation. The measurements during the five study
visits take approximately 20 minutes each time. So there is a time burden.
Zilvermeeuw 1
Almelo 7609PP
NL
Zilvermeeuw 1
Almelo 7609PP
NL
Listed location countries
Age
Inclusion criteria
Patients with ischemic foot ulcers
>=18 years of age
Planned to receive revascularization treatment by standard care practice
protocol.
Willing to give written informed consent and willing and able to comply with
the study protocol
Fontaine 3 and 4
Exclusion criteria
- Patients with contact restrictions.
- Forefoot amputation or larger
- Patients with large wounds or severe gangrene will be excluded when this
would make applying the TcPO2 suction cups impossible.
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 | NL84057.100.23 |