Improving Radiological Outcomes in Arterial Disease - A Pilot Evaluation of the Pedra Tissue Perfusion Monitoring System
Condition: Peripheral Arterial Disease; Chronic Limb Ischemia
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Ischemia
Study type: Observational

Summary: 
      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.
    


Intervention name(s): Pedra Tissue Perfusion Monitor
Intervention type(s): Device
Intervention description(s): This study is a prospective single-centre, device observational study designed to enroll up to 60 evaluable subjects at 1 investigational site in the United Kingdom. Eligible subjects, who meet the requirements for one of the 3 distinct subject groups: (1) Critical Limb Ischaemia group, (2) Peripheral artery disease with superficial femoral arterial (SFA) or popliteal artery disease and (3) PAD-free group. Subjects who meet study eligibility criteria will be enrolled consecutively until the total number of subjects is enrolled per each group as outlined in the protocol. All subjects at the investigational site will be enrolled in the presence of a member of the Sponsor or selected designee in order to assist with the device operation and to verify that all protocol assessments are completed appropriately at baseline.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The 3 distinct subjects groups are divided as such:

          -  Critical Limb Ischaemia (CLI) Group with tibial arterial disease: Up to 20, but at
             least 8 subjects with a 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. The treatment of SFA stenoses of less than 70%, as confirmed
             by duplex or CT, is acceptable in parallel in this group.

          -  Peripheral Artery Disease (PAD) Group with SFA disease: Up to 20, but at least 8
             subjects with a clinical diagnosis of claudication and duplex or CT-confirmed SFA
             stenoses greater than 70%, with no intention of primarily treating any tibial disease
             at this encounter.

          -  PAD-free Group (Healthy Volunteer Group): Up to 20 subjects with no clinical diagnosis
             of peripheral vascular disease.