Improving Radiological Outcomes in Arterial Disease - A Pilot Evaluation of the Pedra Tissue Perfusion Monitoring System
Improving Radiological Outcomes in Arterial Disease - A Pilot Evaluation of the Pedra Tissue Perfusion Monitoring System
The Pedra Technologies' PedraTM device is a non-invasive, diagnostic device intended to
 measure foot perfusion by assessing blood flow. The PedraTM device comprises a compact
 instrument console connected to a sensor that is pasted onto the patient's foot during
 perfusion assessment. Through skin contact, the device is able to monitor tissue perfusion at
 depths of up to 7.5mm. The monitor console contains opto-electronic instrumentation including
 coherent infrared light sources, photo detectors, and display/control electronics. The sensor
 comprises passive fiber-optic conduits, which transfer infrared light from the console to the
 patient, and relays scattered light from the patient back to the console. The intensity of
 light emitted from the sensor is less than 3 mW, well within the safety envelope of Class I
 laser systems and comparable (or lower than) other commercially available devices such as
 laser Doppler systems. The sole point of contact with the patient is a layer of medical grade
 adhesive tape, which is used to paste the flat sensor onto intact skin.
General Inclusion Criteria:

 1. The patient is a male or non-pregnant female ≥ 40 to 90 years of age

 2. The patient is willing to comply with protocol-specified follow-up evaluations

 3. The patient has been informed of the nature of the study, agrees to its provisions and
 has willingly provided written informed consent, approved by the appropriate Ethics
 Committee (EC)

 Cohort Specific Inclusion Criteria:

 Critical Limb Ischaemia Group Inclusion Criteria:

 1. The subject is referred for a percutaneous peripheral revascularisation procedure on
 one of their lower limbs within 2 weeks of Baseline assessments.

 2. Rutherford grade 4 or 5 critically ischemic foot, where the primary intention is to
 treat at least one occluded tibial vessel or 2 severely stenosed tibial vessels.

 Peripheral Arterial Disease Group Inclusion Criteria:

 1. The subject is referred for a percutaneous peripheral revascularisation procedure on
 one of their lower limbs within 2 weeks of Baseline assessments.

 2. This subject must have a clinical diagnosis of claudication and duplex or CT-confirmed
 SFA or popliteal artery stenoses greater than 70%, with no intention of primarily
 treating any tibial disease at this encounter.

 PAD-Free Group Inclusion Criteria:

 1. The subject is recruited voluntarily

 2. Absence of peripheral vascular disease determined by questionnaire and clinical review
 (triphasic signals on hand-held Doppler)

 Exclusion Criteria:

 1. Infusion of vasoactive medications within the past 24 hours

 2. The presence of a known chronic history of anaemia (i.e. Hb <8g/dL)

 3. Congestive heart failure defined by NYHA Classification 3 or 4

 4. The absence of intact skin at suitable measurement sites on the foot.

 5. The presence of invasive soft tissue infection in the toes spreading into the
 forefoot.

 6. The presence of physical impediment to the method of measurements being completed
 (i.e. absent first two toes, extensive ulceration, excessive oedema, pressure
 dressings or heavy bandaging, etc.)

 7. The presence of a non-salvageable foot or a Rutherford 6 wound.

 8. The presence of other conditions, which in the opinion of the Investigator, may
 compromise the subject safety or comfort.

 9. The presence of other conditions, which in the opinion of the Investigator, may
 compromise the accuracy of the data obtained.

 10. The patient is a vulnerable or protected adult, or is unable to provide consent.

 11. The patient is unable to comply with the measurement protocol.

 12. Pregnant subjects