Status:
COMPLETED
Improving Radiological Outcomes in Arterial Disease - A Pilot Evaluation of the Pedra Tissue Perfusion Monitoring System
Lead Sponsor:
Pedra Technology, PTE LTD
Conditions:
Peripheral Arterial Disease
Chronic Limb Ischemia
Eligibility:
All Genders
40-90 years
Brief 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 connec...
Eligibility Criteria
Inclusion
- General
- The patient is a male or non-pregnant female ≥ 40 to 90 years of age
- The patient is willing to comply with protocol-specified follow-up evaluations
- 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
- Critical Limb Ischaemia Group
- The subject is referred for a percutaneous peripheral revascularisation procedure on one of their lower limbs within 2 weeks of Baseline assessments.
- 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
- The subject is referred for a percutaneous peripheral revascularisation procedure on one of their lower limbs within 2 weeks of Baseline assessments.
- 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
- The subject is recruited voluntarily
- Absence of peripheral vascular disease determined by questionnaire and clinical review (triphasic signals on hand-held Doppler)
Exclusion
- Infusion of vasoactive medications within the past 24 hours
- The presence of a known chronic history of anaemia (i.e. Hb \<8g/dL)
- Congestive heart failure defined by NYHA Classification 3 or 4
- The absence of intact skin at suitable measurement sites on the foot.
- The presence of invasive soft tissue infection in the toes spreading into the forefoot.
- 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.)
- The presence of a non-salvageable foot or a Rutherford 6 wound.
- The presence of other conditions, which in the opinion of the Investigator, may compromise the subject safety or comfort.
- The presence of other conditions, which in the opinion of the Investigator, may compromise the accuracy of the data obtained.
- The patient is a vulnerable or protected adult, or is unable to provide consent.
- The patient is unable to comply with the measurement protocol.
- Pregnant subjects
Key Trial Info
Start Date :
May 30 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03294902
Start Date
May 30 2018
End Date
June 30 2020
Last Update
September 21 2020
Active Locations (1)
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1
Addenbrooke's Hospital, Department of Vascular Surgery
Cambridge, United Kingdom, CB2 0QQ