Critical Limb IschemiaPATNCT06007469
Pedal Acceleration Time (PAT) as a Measure of Foot Perfusion
An observational study of Critical Limb Ischemia and Claudication, Intermittent, run by Liverpool University Hospitals NHS Foundation Trust.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia, Claudication, Intermittent
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 4 Oct 2023to 3 Dec 2024
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 1. Male/Female 2. Adults aged 18 and above 3. Willing to provide written, informed consent 4. Referred into the vascular service with symptoms or confirmed PVD/CLTI
Who cannot join
- Referral not indicative of PVD
- Occlusion of vessels/no visible flow at the site of interest
- Amputation of the limb
- Tissue loss preventing assessment
About this study
Official title: Pedal Acceleration Time (PAT) Versus Toe Brachial Pressure Index (TBPI) as a Measure of Foot Perfusion - A Pilot Study.
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.
- Conditions
- Critical Limb Ischemia, Claudication, Intermittent
- Keywords
- ischaemia, ABPI, TBPI, claudication, ulceration, acceleration time, duplex ultrasound
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Intermittent Claudication, Ischemia, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start4 Oct 2023 (estimated)
- Primary completion10 Dec 2023 (estimated)
- Study completion3 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007469
- Sponsor's protocol ID
- SP0721
- Acronym
- PAT
- Status last verified
- Aug 2023
- First submitted
- 27 May 2022
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pedal Acceleration Time (PAT) Versus Toe Brachial Pressure Index (TBPI) as a Measure of Foot Perfusion - A Pilot Study.
- ClinicalTrials.gov ID
- NCT06007469
- Acronym / sponsor ID
- PAT / SP0721
- Conditions
- Critical Limb Ischemia, Claudication, Intermittent
- Keywords
- ischaemia, ABPI, TBPI, claudication, ulceration, acceleration time, duplex ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- 4 Oct 2023 (estimated)
- Primary completion
- 10 Dec 2023 (estimated)
- Study completion
- 3 Dec 2024 (estimated)
- First posted
- 23 Aug 2023 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1. Male/Female 2. Adults aged 18 and above 3. Willing to provide written, informed consent 4. Referred into the vascular service with symptoms or confirmed PVD/CLTI
Key exclusion criteria (4 listed)
- Referral not indicative of PVD
- Occlusion of vessels/no visible flow at the site of interest
- Amputation of the limb
- Tissue loss preventing assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Foot Perfusion.
Time frame: 1 measure
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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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 Critical Limb Ischemia and Claudication, Intermittent, run by Liverpool University Hospitals NHS Foundation Trust.
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 1 inclusion and 4 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 23 Aug 2023. 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?
Foot Perfusion. (time frame: 1 measure). 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 23 Aug 2023.