An observational study in Peripheral Arterial Disease and Chronic Limb Threatening Ischemia, sponsored by University of Edinburgh. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by University of Edinburgh · Observational
Among 22 studies in Chronic Limb-Threatening Ischemia with a site in United Kingdom — 6 open to participants now, 8 under way, none of them phase 3. Chronic Limb-Threatening Ischemia · United Kingdom.
Among the 22 studies in Chronic Limb-Threatening Ischemia with a site in United Kingdom, this one is the 8th largest by planned enrollment of the 10 observational ones that give a count, is one of 2 that started in 2025, is one of 10 observational ones, and was the 20th registered.
356 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 71 are open to participants now.
Browse Chronic Limb-Threatening Ischemia studies →6 of the 22 studies in Chronic Limb-Threatening Ischemia with a site in United Kingdom are open now. Recruiting first, the newest first:
Cardiovascular and Interventional Radiological Society of Europe · Sites in United Kingdom
Cardiovascular and Interventional Radiological Society of Europe · Sites in United Kingdom
University of Leicester · Sites in United Kingdom
University of Manchester · Sites in United Kingdom
Cardiff and Vale University Health Board · Sites in United Kingdom
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 48 Chronic Limb-Threatening Ischemia studies recruiting now, 32 (67%) set no upper age limit and 2 (4%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2025.
This study's planned enrollment of 100 is close to the median of 111 across 102 observational studies indexed under Chronic Limb-Threatening Ischemia.
Median enrollment 49 across the 12 interventional studies, 278 across the 10 observational. Of the 14 that completed or were terminated, 4 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 22 have an industry lead sponsor. The 10 most frequent:
University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.
University of Edinburgh has 1 study filed under Chronic Limb-Threatening Ischemia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 22 studies in Chronic Limb-Threatening Ischemia with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The goal of this observational study is to characterise the relationships between inflammation, microcalcification and thrombus activity in atherosclerotic plaques in peripheral and systemic vascular territories in patients with symptomatic peripheral arterial disease.
In peripheral arterial disease (PAD), arteries in the lower body can become narrowed and develop blockages due to a process called atherosclerosis, leading to reduced blood flow to the lower limbs. Symptoms can range from mild cramping pain in legs on walking, to loss of parts of the leg. Patients with PAD are also at a high risk of blockages in other arteries in the body that can lead to problems such as heart attacks and strokes. Despite improvements in medical treatments and surgery, the outlook for patients with PAD has not improved.
Further information is required to understand the relationships between the processes that lead to narrowing and blockages (atherosclerosis) of the arteries and if they behave the same in different parts of the body. This can help to identify targeted treatments to reduce the risk of the disease getting worse and avoid heart attacks and strokes.
In this study investigators plan to recruit 100 people with symptomatic PAD to undergo a series of whole body PET-CT and CT angiogram scans using different tracers targeting the processes involved in atherosclerosis. Investigators will aim to co-enrol patients taking part in the LEADER-PAD study (NCT04774159).
356 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 71 are open to participants now.
This study's planned enrollment of 100 is close to the median of 111 across 102 observational studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.
Compared within Chronic Limb-Threatening Ischemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Peripheral Arterial Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients will be prosectively recruited from vascular outpatient clinics and inpatient wards.
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.
Symptomatic atherosclerotic peripheral artery disease;
Intermittent claudication; with ankle/arm blood pressure ratio \<0.90 or artery stenosis >50% in addition to at least one of the following;
Exclusion Criteria:
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests 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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Radiation: Whole body [68Ga]DOTATATE PET-CT · Radiation: Whole body [18F]GP1 PET-CT · Radiation: Whole body [18F]NaF PET-CT · Radiation: Whole body CT angiogram
Targeting vascular inflammation
Targeting thrombus activity
Targeting vascular microcalcification
To determine anatomical and morphological atherosclerotic plaque characteristics
Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in the symptomatic lower limb(s)
The 3 primary endpoints will be the location and degree of: 1. inflammation: uptake of \[68Ga\]DOTATATE 2. calcification: uptake of \[18F\]NaF 3. thrombus activity: uptake of \[18F\]GP1 in peripheral arterial disease affecting the lower limbs. This will be determined by the degree of tracer standardised uptake values (SUVs) at the site of the symptomatic atherosclerotic plaque.
Time frame: From baseline imaging until completion imaging at 1 year
Quantification of PET tracer uptake of [68Ga]DOTATATE, [18F]GP1 and [18F]NaF in remote arterial territories
The secondary outcome measures will be the location and degree of inflammation, calcification and thrombus activity in remote arterial territories, including the coronary arteries, cerebral arteries, aorta and mesenteric vessels, as determined by SUVs of \[68Ga\]DOTATATE, \[18F\]NaF and \[18F\]GP1, respectively.
Time frame: From baseline imaging until completion imaging at 1 year
CT plaque morphology
Investigators will characterise CT plaque morphology (total, calcified, non-calcified and low-attenuation plaque) in peripheral and systemic arterial beds and compare this to areas of \[68Ga\]DOTATATE, \[18F\]GP1 and \[18F\]NaF uptake.
Time frame: From baseline imaging to completion imaging at 1 year
The association between patient risk factors for cardiovascular disease and PET tracer uptake
Investigators will explore the association between patient risk factors for cardiovascular disease (hypertension, diabetes, smoking) and the degree of \[68Ga\]DOTATATE, \[18F\]GP1 and \[18F\]NaF uptake as quantified by standard uptake values (SUVs). This will be measured by odds ratio (OR) with 95% confidence interval (CI) for each risk factor-tracer combination.
Time frame: Frome baseline imaging to completion imaging at 1 year
The progression of microcalcification, as defined by [18F]NaF uptake, to macrocalcification.
Investigators will also aim to characterise the relationship between microcalcification progressing to calcification and the uptake of \[18F\]NaF. This will be assessed using baseline and follow-up \[18F\]NaF PET-CT SUVs and their correlation with calcified regions on CT angiography.
Time frame: From baseline imaging to completion imaging at 1 year
Major adverse cardiovascular events (MACE) and major adverse limb events (MALE)
Exploratory endpoints will include major adverse cardiovascular events (acute myocardial infarction, stroke or cardiovascular death) and major adverse limb events (revascularisation or lower limb amputation) as well as death from any cause.
Time frame: From baseline imaging to completion imaging at 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Jul 2028, 36 months after the start.
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 36 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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chronic Limb-Threatening Ischemia →