A Feasibility Study Evaluating A Non-Invasive Tissue Perfusion Monitor Utilising Diffuse Speckle Contrast Analysis

Pedra Technology, PTE LTD0 sites50 target enrollmentDecember 7, 2020

ConditionsCirculatory; Change

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Circulatory; Change
Sponsor: Pedra Technology, PTE LTD
Enrollment: 50
Primary Endpoint: The Blood Perfusion Index (unitless number) delta in response to reduction in arterial inflow pressure
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The Pedra perfusion system will be used to assess changes in perfusion in response to physiological stimuli. It will be compared to other standard diagnostics.

Detailed Description

The Pedra perfusion system measures microvascular flow through diffuse speckle contrast analysis. It will be used to assess changes in perfusion in response to a number of physiological stimuli. It will be compared to other standard diagnostics including ankle-brachial index, toe-brachial index and transcutaneous oxygen measurement. Measurements will be undertaken in non-vascular patients as well as those with chronic limb threatening ischaemia.

Registry

clinicaltrials.gov

Start Date

December 7, 2020

End Date

July 1, 2021

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Pedra Technology, PTE LTD

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•CLTI cohort
•At least 40 years old
•Each patient will have documented arterial occlusive disease within 6 weeks of enrolment as determined by an ankle-brachial index (ABI) \< 0.7 but not greater than 1.2, toe-brachial index (TBI) \<0.5, skin perfusion pressure (SPP) less than 30mmHg, OR Transcutaneous oxygen measurement (TCOM) \< 40mmHg in diabetics and \<30mmHg in non-diabetics.
•The presence of skin breakdown compatible which with an underlying ischemic element (previous minor amputation for gangrene also included) that the Principle Investigator (PI) deems appropriate for the study.
•Subject has read, understood and signed approved consent, and is willing to participate and comply with the study procedures and requirements.
•Non-vascular group
•At least 40 years old
•Each patient will have documented palpable foot pulses
•21 patients will be free of lower limb oedema and 6 patients will have moderate oedema present
•Subject has read, understood and signed approved consent, and is willing to participate and comply with the study procedures and requirements.

Exclusion Criteria

•CLTI Cohort
•Subject on an investigational drug or therapeutic device within 30 days of the study visit, which in the view of the PI may compromise the study results.
•Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
•Age \<40 or \>90
•Inability to straight leg raise to 30 degrees or tolerate calf cuff occlusion.
•Has smoked cigarettes/e-cigarettes on the day of testing.
•Has taken caffeine drinks on the day of testing
•In the last 3 hours the subject has exercised beyond normal daily walking.
•Inability to have TBI measured (e.g. absence of toe)
•Signs of active infection causing localised inflammation on the plantar or dorsal surfaces of the foot

Outcomes

Primary Outcomes

The Blood Perfusion Index (unitless number) delta in response to reduction in arterial inflow pressure

Time Frame: Intra-procedure

The range of change in the Blood Perfusion Index (unitless) in response to physiologic changes in arterial perfusion, in patients with healthy circulation and those with compromised arterial circulation

Secondary Outcomes

Sensitivity of Pedra to detect differences in the Blood Perfusion Index between patient subsets(Intra-procedure)
Reliability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient(intra-procedure)
Repeatability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient(intra-procedure)