A multicentre study to use non-invasive methods including hyperSPECTral imaging, thermal imaging and tcPO2 for monitoring tissue perfusion in vAsCULAR patients in-hospital and at home -- The SPECTACULAR-study

Peripheral arterial disease (PAD) is a progressive and common disease. Symptoms
and complications of PAD, including ulceration, are a result of impaired tissue
perfusion. To detect and determine the severity of PAD, effective diagnostics
are necessary. Current diagnostic methods used for PAD can only detect arterial
inflow but do not measure tissue perfusion. It is essential to determine tissue
perfusion because impaired perfusion of oxygenated blood is the direct cause of
symptoms. The gold standard to determine tissue perfusion is transcutaneous
partial pressure of oxygen (tcPO2) measurements. However, quality of evidence
for the method in PAD patients is low and the device has some limitations. For
example, this method is expensive, time consuming and not suited for everyday
clinical use. Hyperspectral imaging is a novel, non-invasive method to
determine tissue perfusion by measuring oxyhemoglobin, deoxyhemoglobin and
oxygen saturation transcutaneous. Additionally, thermal imaging is a
non-invasive method to determine local changes in skin temperature, which
correlates with vascular disease and ulceration. It is still uncertain, which
of these devices can be used for assessment of tissue perfusion in the PAD
patients. These imaging devices are hand-held and can easily be performed by
health professionals in-hospital and in a home setting. This enables the use of
these methods in the pre-intervention phase, during revascularisation and
during the complete post-interventional follow-up. We hypothesize that
hyperspectral imaging, thermal imaging and tcPO2 can be used to assess tissue
perfusion during the complete care process of patients with peripheral arterial
disease.

Our main objective is to determine normal ranges for oxyhemoglobin,
deoxyhemoglobin, oxygen saturation, local skin temperature and tcPO2 during all
phases (pre-/per-/post-intervention) of treatment of peripheral arterial
disease. Secondary objectives include, to correlate hyperspectral imaging,
thermal imaging and tcPO2 measurements to standard diagnostics such as
ankle/brachial index (ABI), systolic toe blood pressure (TBP) and treadmill
test and degree of stenosis on CTA. In addition, to correlate hyperspectral
imaging, thermal imaging and tcPO2 measurements to wound healing, to clinical
outcome and to the origin of non-healing foot ulcers. Data on patient
demographics, lifestyle and quality of life are also recorded.

This study is a multicentre, prospective longitudinal cohort study. Patients
suspected and/ or diagnosed with peripheral arterial disease will be included.
Patients who will not be diagnosed with peripheral arterial disease, will not
further participate in this study. All patients diagnosed with peripheral
arterial disease will receive diagnostics and treatment according to standard
of care. In addition, hyperspectral imaging, tcPO2 and thermal imaging will be
performed before, during, and after treatment in the patients diagnosed with
peripheral arterial disease.

The risks associated in this study are very low. The HyperView hyperspectral
imaging device is a CE certified, non-invasive, easy to use device. It will be
used according to its intended use. tcPO2, ABI, TBP and treadmill test are
routinely performed on patients with PAD. The additional measurements will be
performed during normally scheduled appointments and during home visits.
Patients will be asked to complete a survey three times during the study.
Therefore, the burden of participating in this study is very low. There are no
direct benefits for patients concerning the treatment they are receiving.