ClinicalTrials.gg
Status unknownNCT04630704Updated Nov 16, 2020

Evaluating A Non-Invasive Tissue Perfusion Monitor

An observational study in Circulatory; Change, sponsored by Pedra Technology, PTE LTD. Status unknown. Open to participants aged 40 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-16.

Sponsored by Pedra Technology, PTE LTD · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
50
Ages
40 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Circulatory; Change

Keywords

  • Microvascular
  • Perfusion
03

In context

Lead sponsor

Pedra Technology, PTE LTD is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with palpable pulses and patients with chronic limb threatening ischaemia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

CLTI Cohort

  1. Subject on an 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DevicePedra

    Diffuse speckle contrast analysis perfusion system

06

What researchers measure

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

    Time frame: Intra-procedure

Secondary outcomes

  1. 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

    Time frame: intra-procedure

  2. 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

    Time frame: intra-procedure

  3. 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

    Time frame: Intra-procedure

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — No plan to share data

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2020; primary completion for Apr 2021, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2020
First posted
Nov 16, 2020
StartEst.
Dec 7, 2020
Primary completionEst.
Apr 1, 2021
CompletionEst.
Jul 1, 2021
Last update
Nov 16, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04630704
Lead sponsor
Pedra Technology, PTE LTD
Collaborators
Serena Group
Responsible party
Sponsor
First posted
Nov 16, 2020
Start date
Dec 7, 2020 (estimated)
Primary completion
Apr 1, 2021 (estimated)
Completion
Jul 1, 2021 (estimated)
Last update
Nov 16, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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