Circulatory; ChangeNCT04630704
Evaluating A Non-Invasive Tissue Perfusion Monitor
An observational study of Circulatory; Change, run by Pedra Technology, PTE LTD.
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. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Circulatory; Change
- What is being tested?
- Pedra
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2020to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with palpable pulses and patients with chronic limb threatening ischaemia
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
- 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.
About this study
Official title: A Feasibility Study Evaluating A Non-Invasive Tissue Perfusion Monitor Utilising Diffuse Speckle Contrast Analysis
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.
Read the 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.
- Conditions
- Circulatory; Change
- Being tested
- Pedra
- Keywords
- Microvascular, Perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PedraDevice
Diffuse speckle contrast analysis perfusion system
| Study group | Role | What they receive |
|---|---|---|
| Non vascular repeatibility | This cohort of patients with palpable pulses will be used to test inter- and intra- observer variability for the Pedra system Receives: 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. Receives: 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. Receives: Device: Pedra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Intra-procedure
Secondary outcomes (3)
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
Measured: intra-procedure
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
Measured: intra-procedure
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
Measured: Intra-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start7 Dec 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory; ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pedra Technology, PTE LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630704
- Sponsor's protocol ID
- Pedra-001
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Evaluating A Non-Invasive Tissue Perfusion Monitor Utilising Diffuse Speckle Contrast Analysis
- ClinicalTrials.gov ID
- NCT04630704
- Acronym / sponsor ID
- Pedra-001
- Conditions
- Circulatory; Change
- Keywords
- Microvascular, Perfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Pedra Technology, PTE LTDIndustry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Study start
- 7 Dec 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non vascular repeatibility | – | Device: PedraThis cohort of patients with palpable pulses will be used to test inter- and intra- observer variability for the Pedra system |
| Non vascular physiology | – | Device: PedraThis cohort of patients with palpable pulses will assess the ability of Pedra to detect perfusion changes in response to physiologic stimuli. |
| CLTI physiology | – | Device: PedraThis cohort of patients with CLTI will assess the ability of Pedra to detect perfusion changes in response to physiologic stimuli. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with palpable pulses and patients with chronic limb threatening ischaemia
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PedraDiffuse speckle contrast analysis perfusion system | Device | CLTI physiology, Non vascular physiology, Non vascular repeatibility |
Primary outcome
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
3 secondary outcomes
Reliability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient
Time frame: intra-procedure
Repeatability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient
Time frame: intra-procedure
Sensitivity of Pedra to detect differences in the Blood Perfusion Index between patient subsets
Time frame: Intra-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Individual participant dataSharing planned: No. No plan to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulatory; Change, run by Pedra Technology, PTE LTD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Blood Perfusion Index (unitless number) delta in response to reduction in arterial inflow pressure (time frame: Intra-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.