An observational study in Peripheral Arterial Disease and Chronic Limb Ischemia, sponsored by Pedra Technology, PTE LTD. Completed at 1 site in United Kingdom. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-09-21.
Sponsored by Pedra Technology, PTE LTD · Observational
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.
The 3 distinct subjects groups are divided as such:
General Inclusion Criteria:
Cohort Specific Inclusion Criteria:
Critical Limb Ischaemia Group Inclusion Criteria:
Peripheral Arterial Disease Group Inclusion Criteria:
PAD-Free Group Inclusion Criteria:
Exclusion Criteria:
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.
Device: Pedra Tissue Perfusion Monitor
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.
Device: Pedra Tissue Perfusion Monitor
Up to 20 subjects with no clinical diagnosis of peripheral vascular disease.
Device: Pedra Tissue Perfusion Monitor
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.
Baseline safety endpoint: The absence of immediately observable skin reaction (rash; local oedema, blistering of the skin) in ≥ 90% of subjects after removal of the Pedra sensors.
This observation assessment is completed by the physician post removal of the adhesive pads. It is either a "yes" or a "no" in observing if there is a skin reaction to the adhesive pads when they are removed from the skin and also documentation of what type of reaction (rash; local oedema, blistering of the skin).
Time frame: Baseline visit: 30-60 minutes after pad removal
During procedure safety endpoint: The absence of immediately observable skin reaction (rash; local oedema, blistering of the skin) in ≥ 90% of subjects after removal of the Pedra sensors.
This observation assessment is completed by the physician post removal of the adhesive pads. It is either a "yes" or a "no" in observing if there is a skin reaction to the adhesive pads when they are removed from the skin and also documentation of what type of reaction (rash; local oedema, blistering of the skin).
Time frame: During procedure visit: 30-60 minutes after pad removal
36-hrs post-procedure/ discharge visit safety endpoint: The absence of immediately observable skin reaction (rash; local oedema, blistering of the skin) in ≥ 90% of subjects after removal of the Pedra sensors.
This observation assessment is completed by the physician post removal of the adhesive pads. It is either a "yes" or a "no" in observing if there is a skin reaction to the adhesive pads when they are removed from the skin and also documentation of what type of reaction (rash; local oedema, blistering of the skin).
Time frame: 36-hrs post-procedure/ discharge visit: 30-60 minutes after pad removal
Plan to share: No
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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Pedra Technology, PTE LTD