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Not yet recruitingNCT06007469PATUpdated Aug 23, 2023

Pedal Acceleration Time (PAT) as a Measure of Foot Perfusion

An observational study in Critical Limb Ischemia and Claudication, Intermittent, sponsored by Liverpool University Hospitals NHS Foundation Trust. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-23.

Sponsored by Liverpool University Hospitals NHS Foundation Trust · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

To identify a correlation between Toe Brachial pressure Index (TBPI) and Acceleration time of the pedal vessels. The aim would then to use this data to design a clinical study assessing the relationship between PAT and wound healing in patients with PAD.

Read the detailed description

The use of ankle brachial pressure index (ABPI) is commonplace in the screening, diagnosis and management of peripheral vascular disease (PAD). This technique measures and compares the occlusion pressure of the brachial arteries for comparison with the occlusion pressure of the tibial arteries at the level of the ankle. The index is then calculated by dividing the highest of the tibial occlusion pressures by the highest brachial occlusion pressure. In normal subjects the ABPI should fall between 09-1.3 (1) . A pressure less than 0.9 suggest a compromise to the peripheral circulation (PAD), with the blood pressure at the ankle level being lower than in the arm. ABPI results can be erroneous in the presence of medial artery calcification (MAC) where the ankle arteries are more difficult to compress and hence give falsely elevated readings. In some patients it can be impossible to occlude the arterial flow as the vessel is so rigid (1). Conditions that increase the prevalence of MAC are diabetes mellitus, chronic kidney disease as well as advancing age which also increased the stiffness of the vessel walls having a similar effect as MAC (2).

When used in isolation as a PAD screening, ABPI can give a normal reading due to undiagnosed pathological vessel stiffness with studies reporting up to 14-27% of patients returning normal ABPI results at the same time as low TBPI. (3) Despite the potential pitfall of ABPI, it is still a widely recognized as its diagnostic limits have been validated in several large scale studies. (3) However, due to the level of arterial assessment, ABPI does not actually assess circulation into the foot itself (4). The toe vessels are much less susceptible to vessel stiffness (3) , and hence deemed are more reliable in such cases when the ABPI would return a falsely elevated result.

When used alongside detailed duplex imaging of the peripheral arterial tree to give image guided documentation of vessel calcification, TBPI is a useful indicator of perfusion into the foot when the ABPI is known not to be indicated. Therefore TBPI measurement has become the established method for assessing arterial perfusion to the foot, particularly in patients with risk factors for MAC.

When investigating perfusion into the critically ischaemic limb, ABPI is not indicated and therefore TBPI is the preferred method. However this becomes problematic when there has been previous amputation of the forefoot/toes, the patient is in significant pain and/or there is tissue loss which impedes accurate placement of the equipment on the affected limb. Furthermore, in a significant number of these patients it is not possible to obtain an adequate waveform in the toe due to poor arterial perfusion.

To overcome this predicament a novel technique has been developed which involves direct ultrasound imaging of the pedal vasculature and use the systolic rise time calculated from the returned waveform analysis as a surrogate for ABPI (4) This systolic rise time, known as pedal acceleration time (PAT) in foot vessels, has been has been reported to correlate well with ABPI in patients with compressible vessels and therefore is felt to be a predictor of wound healing following direct and indirect revascularization. (4) There are, however, a significant group of patients that attend the vascular department that have risk factors for MAC which make them unsuitable for ABPI. For this group of patients and those with coexisting with foot wounds/previous amputation, there is no ratified method for investigation perfusion pressure.

The aim of this pilot study is to gather information from all patients who present with significant PAD to investigate a possible link between PAT, ABPI and TBPI and if PAT is a reliable measurement in patients who fall outside of the group normally excluded.

This would allow objective perfusion information and therefore guide treatment and management plans.

02

Conditions studied

  • Critical Limb Ischemia
  • Claudication, Intermittent

Keywords

  • ischaemia
  • ABPI
  • TBPI
  • claudication
  • ulceration
  • acceleration time
  • duplex ultrasound
03

In context

Chronic Limb-Threatening Ischemia

356 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 71 are open to participants now.

This study's planned enrollment of 50 is below the median of 111 across 102 observational studies indexed under Chronic Limb-Threatening Ischemia.

Browse Chronic Limb-Threatening Ischemia studies →

Lead sponsor

Liverpool University Hospitals NHS Foundation Trust is the lead sponsor of 61 studies on the registry; 13 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients will be identified who attend the vascular clinic at the Royal Liverpool Hospital. The first 30 patients with critical limb threatening ischaemia (CLTI) that are identified and consent for the study will be recruited. Similarly the first 20 patients who have symptoms suggestive of non-critical, peripheral arterial disease such as intermittent claudication will be recruited.

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

    1. Male/Female 2. Adults aged 18 and above 3. Willing to provide written, 4. Referred into the vascular service with symptoms or confirmed PVD/CLTI

Exclusion criteria

Exclusion Criteria:

  1. Referral not indicative of PVD
  2. Occlusion of vessels/no visible flow at the site of interest
  3. Amputation of the limb
  4. Tissue loss preventing assessment
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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Critical Limb Threatening Ischaemia

    Patients presenting with Critical Limb Threatening Ischaemia

  • Non-limb threatening peripheral vascular disease

    Patients presenting with non-limb threatening peripheral vascular disease

06

What researchers measure

Primary outcomes

  1. Foot Perfusion.

    ankle arterial acceleration time versus toe pressure (mmHg) Manual blood pressures of at the toe (mmHg) will also be measured from all participants, where technically possible.

    Time frame: 1 measure

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2023; primary completion for Dec 2023, 2 months later.

Of 46 non-industry observational studies under Chronic Limb-Threatening Ischemia, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 60. This study's planned 2 months is below that.

Counting every sponsor, half of 51 studies reached it within 34 months; a quarter within 22 and three quarters within 59.

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

Registered
May 27, 2022
First posted
Aug 23, 2023
StartEst.
Oct 4, 2023
Primary completionEst.
Dec 10, 2023
CompletionEst.
Dec 3, 2024
Last update
Aug 23, 2023
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 Aug 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06007469
Lead sponsor
Liverpool University Hospitals NHS Foundation Trust
Responsible party
Sponsor
First posted
Aug 23, 2023
Start date
Oct 4, 2023 (estimated)
Primary completion
Dec 10, 2023 (estimated)
Completion
Dec 3, 2024 (estimated)
Last update
Aug 23, 2023

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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