Evaluating A Non-Invasive Tissue Perfusion Monitor

Circulatory; Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04630704
• Other study ID #: Pedra-001
• Status: Not yet recruiting
• Start date: December 7, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: November 2020
• Source: Pedra Technology, PTE LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Circulatory; Change

Intervention

Device:
• Pedra
Diffuse speckle contrast analysis perfusion system

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pedra Technology, PTE LTD	Serena Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reliability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient	The reliability of measurement of the Blood Perfusion Index will be measured and compared to standard diagnostics	intra-procedure
Secondary	Repeatability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient	The repeatability of measurement of the Blood Perfusion Index will be measured and compared to standard diagnostics	intra-procedure
Secondary	Sensitivity of Pedra to detect differences in the Blood Perfusion Index between patient subsets	Use of a ROC curve to assess the ability of the Blood Perfusion Index to differentiate between those with healthy circulation and those with arterial disease	Intra-procedure