Clinical trial NCT04630704: Evaluating A Non-Invasive Tissue Perfusion Monitor
Official title: A Feasibility Study Evaluating A Non-Invasive Tissue Perfusion Monitor Utilising Diffuse Speckle Contrast Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Circulatory; Change
Keywords: Microvascular
Perfusion
Lead sponsor: Pedra Technology, PTE LTD
Sponsor class: INDUSTRY
Collaborators: name: Serena Group
First posted: 2020-11-16
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with palpable pulses and patients with chronic limb threatening ischaemia

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.

Eligibility criteria: Inclusion Criteria:

CLTI cohort

1. At least 40 years old
2. 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.
3. 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.
4. Subject has read, understood and signed approved consent, and is willing to participate and comply with the study procedures and requirements.

Non-vascular group

1. At least 40 years old
2. Each patient will have documented palpable foot pulses
3. 21 patients will be free of lower limb oedema and 6 patients will have moderate oedema present
4. 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

1. 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.
2. Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
3. Age \<40 or \>90
4. Inability to straight leg raise to 30 degrees or tolerate calf cuff occlusion.
5. Has smoked cigarettes/e-cigarettes on the day of testing.
6. Has taken caffeine drinks on the day of testing
7. In the last 3 hours the subject has exercised beyond normal daily walking.
8. Inability to have TBI measured (e.g. absence of toe)
9. Signs of active infection causing localised inflammation on the plantar or dorsal surfaces of the foot
10. Pathological skin conditions that may impair the ability of the adhesive sensor pads to adhere.

Non-vascular Cohort

1. 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.
2. Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
3. Age \<40 or \>90
4. Inability to straight leg raise to 30 degrees or tolerate calf cuff occlusion.
5. Has smoked cigarettes/e-cigarettes on the day of testing.
6. Has taken caffeine drinks on the day of testing
7. In the last 3 hours the subject has exercised beyond normal daily walking.
8. Inability to have TBI measured (e.g. absence of toe)
9. Signs of active infection causing localised inflammation on the plantar or dorsal surfaces of the foot
10. Pathological skin conditions that may impair the ability of the adhesive sensor pads to adhere.

Primary outcomes:
measure: The Blood Perfusion Index (unitless number) delta in response to reduction in arterial inflow pressure
timeFrame: Intra-procedure
Secondary outcomes:
measure: Reliability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient
timeFrame: intra-procedure
measure: Repeatability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient
timeFrame: intra-procedure
measure: Sensitivity of Pedra to detect differences in the Blood Perfusion Index between patient subsets
timeFrame: Intra-procedure
Other outcomes:
Locations:
Study officials:
References: