Evaluating A Non-Invasive Tissue Perfusion Monitor

NCT04630704 | Unknown FDA Device

• 1 other identifier: Pedra-001
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Circulatory; Change

Keywords

Microvascular; Perfusion

Outcome Measures

Primary Outcomes (1)

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

  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

  Intra-procedure

Secondary Outcomes (3)

• 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

• Sensitivity of Pedra to detect differences in the Blood Perfusion Index between patient subsets

  Intra-procedure

Study Arms (3)

Non vascular repeatibility

This cohort of patients with palpable pulses will be used to test inter- and intra- observer variability for the Pedra system

Device: Pedra

Non vascular physiology

This cohort of patients with palpable pulses will assess the ability of Pedra to detect perfusion changes in response to physiologic stimuli.

Device: Pedra

CLTI physiology

This cohort of patients with CLTI will assess the ability of Pedra to detect perfusion changes in response to physiologic stimuli.

Device: Pedra

Interventions

Pedra DEVICE

Diffuse speckle contrast analysis perfusion system

CLTI physiology; Non vascular physiology; Non vascular repeatibility

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with palpable pulses and patients with chronic limb threatening ischaemia

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• Pathological skin conditions that may impair the ability of the adhesive sensor pads to adhere.
• Non-vascular 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

Sponsors & Collaborators

• Pedra Technology, PTE LTD: lead
• Serena Group: collaborator

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 16, 2020
• Study Start: December 7, 2020
• Primary Completion: April 1, 2021
• Study Completion: July 1, 2021
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share