[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intermittent-claudication\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intermittent-claudication":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,45,71,104,135,168,196,222,251,281],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100644498","predictors-of-major-adverse-limb-events-after-endovascular-iliac-stenting-a-real-world-cohort-study-100644498",false,"NCT07672249","Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study","Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study (PREMISE-ILIAC Study)","PREMISE-ILIAC","Inclusion Criteria:\n\nAdult patients aged ≥18 years, of both male and female sex\n\n* Presence of haemodynamically significant stenosis or occlusion of the common iliac artery (CIA) and\u002For external iliac artery (EIA), documented by computed tomography angiography, magnetic resonance angiography, or diagnostic angiography\n* Symptomatic peripheral artery disease, including lifestyle-limiting intermittent claudication (Rutherford category 2-3) or chronic limb- threatening ischaemia (CLTI; Rutherford category 4-6), refractory to optimal medical therapy\n* Treatment with endovascular iliac artery stenting (covered or uncovered; balloon-expandable or self-expanding devices) as the primary revascularisation strategy\n* De novo iliac lesions only\n* Availability of complet\n\nExclusion Criteria:\n\nPrimary open surgical revascularisation of the iliac axis (e.g., aorto- bifemoral bypass or endarterectomy).\n\n* Previous stenting of the target iliac segment (in-stent restenosis cases excluded).\n* Aorto-iliac aneurysmal disease as the primary indication for treatment (including EVAR or fenestrated endografts).\n* Hybrid procedures with concomitant infrainguinal bypass surgery.\n* Incomplete clinical, procedural, or follow-up data preventing assessment of study endpoints.\n* Loss to follow-up without documented clinical outcomes.","ALL","18 Years",{"count":20,"type":21},98,"ESTIMATED","OBSERVATIONAL","Peripheral arterial disease involving the iliac arteries is a common manifestation of systemic atherosclerosis and a major cause of lifestyle-limiting claudication and chronic limb-threatening ischemia. Endovascular iliac artery stenting has become the preferred treatment strategy for most iliac lesions, including complex TransAtlantic Inter-Society Consensus II (TASC II) C and D lesions, owing to high technical success rates and lower perioperative morbidity compared with open surgical reconstruction.\n\nDespite widespread adoption of endovascular treatment, available evidence regarding predictors of major adverse limb events (MALE) after iliac artery stenting remains limited, particularly in unselected real-world populations with substantial comorbidity burden. Patient-related factors, including frailty, may contribute to post-procedural outcomes in addition to lesion-related characteristics.\n\nThis retrospective single-center cohort study will evaluate clinical outcomes following endovascular iliac artery stenting in consecutive adult patients treated at IRCCS Galeazzi-Sant'Ambrogio Hospital, Milan, Italy. The study will assess the occurrence of major adverse limb events (MALE), primary patency, peri-procedural complications, target lesion revascularization, restenosis or occlusion, and all-cause mortality. Clinical, anatomical, and procedural factors associated with adverse limb outcomes, including frailty assessed by the modified five-item Frailty Index (mFI-5), will also be investigated.",[25,26,27,28],"Peripheral Arterial Disease","Aortoiliac Occlusive Disease","Chronic Limb-Threatening Ischemia","Intermittent Claudication",[25,30,31],"Iliac Artery Stenting","Endovascular Revascularization","RECRUITING","2026-06-26",{"date":35,"type":36},"2026-06-30","ACTUAL",{"date":38,"type":36},"2026-06-16",{"date":40,"type":21},"2026-07-16",{"name":42,"class":43},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":44},"100640911","local-and-systemic-macrophage-activation-in-coronary-and-peripheral-artery-disease-100640911","NCT07588295","Local And Systemic Macrophage Activation in Coronary and Peripheral Artery Disease","Local And Systemic Macrophage Activation in Coronary and Peripheral Artery Disease: the LAST-COP Study","Inclusion Criteria:\n\n* Patients with chronic coronary artery disease;\n* Patients with no-ST elevation acute coronary syndrome;\n* Patients with chronic claudication (Rutherford II-III)\n* Patients with critical limb ischemia (Rutherford IV-V).\n\nExclusion Criteria:\n\n* Severe renal dysfunction\n* Severe valve disease\n* Advanced heart failure\n* Advanced liver disease\n* Chronic inflammatory or autoimmune disease\n* Use of antinflammatory drugs\n* Acute infection\n* Recent surgical procedures",{"count":53,"type":21},60,"INTERVENTIONAL",[56],"NA","Numerous clinical studies have highlighted the role of macrophages in the destabilization of coronary lesions; however, there is limited literature on the relationship between circulating monocytes and intraplaque macrophages.\n\nThis study aims to evaluate and compare the presence of macrophages and their subsequent activation within coronary and peripheral atherosclerotic lesions, and to correlate these findings with the distribution of circulating monocyte subpopulations.",[59,60,61,28],"Stable Coronary Artery Disease","Acute Coronary Syndromes","Critical Limb Ischemia","2026-05-11",{"date":64,"type":36},"2026-05-14",{"date":66,"type":36},"2024-03-18",{"date":68,"type":21},"2026-12",{"name":70,"class":43},"Maria Cecilia Hospital",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":54,"phases":83,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":44},"100449435","phase-3-metformin-benefits-lower-extremities-with-intermittent-claudication-100449435","NCT05132439","MetfOrmin BenefIts Lower Extremities With Intermittent Claudication","Metformin BenefIts Lower Extremities With Intermittent Claudication (MOBILE_IC)","MOBILE IC","Inclusion Criteria:\n\n* Male and Female Veteran \\>35 \\& \\\u003C89\n* Symptoms of Intermittent claudication\n* Medically stable, optimal medical therapy (for \\>3 months prior to randomization which includes - statin and anti-platelet therapy, blood pressure control, smoking cessation and physical activity counseling)\n\n  a. Participants may not comply with the above measures to meet inclusion criteria, but investigator driven attempts to maximize the optimal medical therapy, as tolerated, for each participant prior to trial enrollment\n* PAD as defined by ABI \\\u003C0.9 or \\>0.9 with evidence of PAD as documented by pulse volume recordings (within 6 months prior to expected randomization date)\n* Maximum Walking Distance (MWD) on the 6-minute walk test (6MWT) of greater than or equal to 50 meters with onset of pain before or at 400 meters without the use of a walker (cane is acceptable; within 6 months of expected randomization date)\n\nExclusion Criteria:\n\n* Diabetes (Type I or II) or Hemoglobin A1c\\>6.5 (within 6 months of expected randomization)\n* Currently Taking metformin or have previously taken metformin (within 6 months of enrollment)\n* Medical condition that limit their ability to ambulate other than PAD (i.e., Angina, CHF, pulmonary disease requiring oxygen, malignancy requiring treatment, etc.)\n* Prior above or below knee amputation\n* Critical limb threatening ischemia (i.e., non-healing wounds or rest pain)\n* Planned hospital admission, major operation, or lower extremity revascularization to be completed (within 12 months after expected randomization date)\n* Prior major operation or lower extremity revascularization (within the 3 months before expected randomization)\n* Unable to complete quality of life testing due to Non-English Speaking and\u002For Dementia\n* Kidney disease - dialysis or eGFR\\\u003C45 (within 6 months of expected randomization date)\\*\n* Planned iodinated contrasted study (within 6 months of expected randomization date)\n* Evidence current or history of hepatic failure\n* Women who are pregnant or breast feeding\n* Unable to swallow uncrushed pills\n* Investigator expects inclusion could cause harm to subject","35 Years","89 Years",{"count":82,"type":21},200,[84],"PHASE3","Peripheral arterial disease (PAD) affects over 20% of aged adults and is very common among Veterans due significant tobacco use. PAD is due to the progressive blockage of peripheral arteries, predominantly to the legs, and results in intermittent claudication (IC) or recurrent muscle pain with activity secondary to insufficient blood supply. Those with PAD and IC experience a progressive decline in walking and poor quality of life. There is no effective medical treatment for PAD and IC. Metformin is a safe and effective treatment for Type 2 diabetes but it can also reduce inflammation, oxidative stress, and improve energy requirements as well as improve blood flow to the legs. Therefore, the investigators will test the ability of Metformin to improve overall functional status, reduce PAD progression, and reduce systemic inflammation in Veterans suffering from PAD and IC in a randomized, placebo controlled trial: Metformin BenefIts Lower Extremities with Intermittent Claudication (MOBILE IC) Trial. The success of this trial may identify a safe and effective treatment for PAD and IC.",[28],[88,89,90,91,92,93],"Peripheral artery disease","intermittent claudication","metformin","anti-inflammatory agents","clinical trial protocol","atherosclerosis","2026-04-16",{"date":96,"type":36},"2026-04-21",{"date":98,"type":36},"2022-03-01",{"date":100,"type":21},"2032-02-28",{"name":102,"class":103},"VA Office of Research and Development","FED",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":54,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":44},"100524899","motivating-physical-activity-with-behavioural-intervention-and-electrical-stimulation-remotely-in-intermittent-claudication-100524899","NCT06114732","Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in Intermittent Claudication","Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in People With Intermittent Claudication (MAvERIC): a Feasibility Randomised Controlled Trial","MAvERIC","Inclusion Criteria:\n\n* Clinical diagnosis of symptomatic Peripheral Arterial Disease (PAD) including resting ABPI \\\u003C0.9 in at least one leg\n* Stable IC for ≥3 months\n* Walking limited primarily by claudication\n* Able to read and speak English to a level allowing satisfactory completion of the study procedures\n* Able to provide written informed consent for participation\n\nExclusion Criteria:\n\n* Planned surgical or endovascular intervention for PAD within the next 3 months\n* Critical limb ischaemia\n* The presence of any absolute contraindications to exercise testing\u002Ftraining as defined by the American College of Sports Medicine (ACSM)\n* Previous experience of using TENS for PAD\n* Contraindications to TENS (including epilepsy, dermatological conditions, indwelling electrical pumps\u002Fpacemakers) and inability to apply TENS independently.\n* Patients who require walking aids including artificial limbs\n* Major surgery, myocardial infarction or stroke\u002F TIA in the previous 6 months\n* Co-morbidities that cause pain or limit walking to a greater extent than IC (e.g. severe arthritis, respiratory conditions)\n* Severe peripheral neuropathies above the ankle.\n* Participation in another research protocol",{"count":113,"type":21},48,[56],"Peripheral Arterial Disease (PAD) is a common vascular disease which commonly causes limb pain and reduced exercise tolerance termed Intermittent Claudication (IC). People with PAD and IC have impaired quality of life, reduced walking ability, and increased mortality compared to those who do not have the condition.\n\nImproving physical activity (PA) is important in individuals with IC it can improve function, morbidity and mortality rates. While supervised exercise classes are recommended by healthcare authorities they are geographically sparse, and not always accessible due to individuals walking limitations. While home-based exercise can be accessible and improve walking ability, it can be challenging for people with IC to initially plan, conduct, and stay motivated to complete a walking program unsupported, especially when they experience limb pain when walking.\n\nInvestigators have shown that Transcutaneous Electrical Nerve Stimulation (TENS), a non-invasive pain management device, with aims to improve pain and walking distances in patients with IC may be an acceptable modality alongside advice and support from a physiotherapist to overcome these challenges. Investigators have also shown that motivational interviewing, education, and goal-setting with a physiotherapist (physical therapist) has the potential to increase PA, and quality of life.\n\nThis study aims to conduct a feasibility trial of four telehealth physiotherapy sessions, alongside the provision of a CE-marked TENS device to reduce limb pain during physical activity. This will be compared to the usual care offered in NHS Lanarkshire",[117,28],"Peripheral Artery Disease",[119,120,121,122,123,124,125],"Transcutaneous electrical nerve stimulation","Electrical Stimulation","Pain Management","Physiotherapy","Education","Motivational Interviewing","Feasibility","2025-08-25",{"date":128,"type":36},"2025-09-02",{"date":130,"type":36},"2024-01-29",{"date":132,"type":21},"2026-12-01",{"name":134,"class":43},"Glasgow Caledonian University",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":54,"phases":145,"briefSummary":146,"conditions":147,"keywords":151,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":167},"100568814","phase-3-improving-mobility-after-revascularization-in-peripheral-artery-disease-100568814","NCT06686121","Improving Mobility After Revascularization in Peripheral Artery Disease","IMProving Mobility After revasCularizaTion in Peripheral Artery Disease: The IMPACT PAD Trial","IMPACT PAD","Inclusion Criteria:\n\nSuccessful lower extremity revascularization for disabling PAD performed at least 30 days before baseline testing and between 30 and 100 days before randomization.\n\nExclusion Criteria:\n\n1. History of leg amputation, not including toe and partial foot amputation\n2. Active gangrene\n3. Active limb threatening ischemia\n4. Already exercising at a level consistent with exercise intervention, using investigator discretion.\n5. Unstable angina\n6. Unwilling to drink study beverages\n7. Unwilling to adhere to the interventions and complete follow-up testing\n8. Currently taking sildenafil, tadalafil, or related drugs.\n9. Unwilling to accept randomization into either group (home-based exercise or attention control)\n10. Currently consuming beetroot juice, oral nitrate or nitrite, or a beetroot supplement and\u002For unwilling to avoid beetroot juice during the study. Participants will be asked to discontinue these items for 30 days before baseline testing and throughout the clinical trial. If the potential participant is unwilling to refrain from taking these items, they will not be eligible for the clinical trial.\n11. History of kidney stones that requires minimized intake of oxalate. Potential participants who need to minimize oxalate intake will be excluded from the trial.\n12. Baseline blood pressure \\\u003C100\u002F45.\n13. Wheelchair confinement or requiring a walker to ambulate\n14. Walking is limited by a condition other than PAD\n15. Current foot ulcer\n16. Planned major surgery, coronary revascularization, or lower extremity revascularization during the next 12 months\n17. Major medical illness including lung disease requiring oxygen, Parkinson's disease, or a life-threatening illness with life expectancy less than six months.\n18. Allergy to beetroot juice\n19. Currently consuming one cup or more of beets daily. Participants will be asked to decrease beet consumption to less than one cup of beets per day for 14 days before baseline testing and throughout the clinical trial. If the potential participant is unwilling to refrain from daily beet consumption of one cup or more for 30 days before the trial and during the trial, they will not be eligible for the clinical trial.\n20. Participation in or completion of a clinical trial in the previous three months, using investigator discretion for trials that may not impact study participation or outcome measures of the IMPACT PAD Trial.\n21. Visual impairment that limits walking ability.\n22. Unable to communicate in English, unless the participant communicates in Spanish and is enrolled at a site that can deliver the intervention in Spanish. All sites with a Spanish speaking coordinator and interventionist will be able to enroll Spanish-speaking participants. While investigators aim to be as inclusive as possible, resources are not available to allow inclusion of people speaking languages that are not Spanish or English.\n23. Using a mouthwash containing chlorhexidine or cetylpyridinium chloride or a mouthwash determined to be bactericidal and unwilling to discontinue.\n24. Planning to begin a supervised treadmill exercise program in the next 12 months.\n25. Heart attack or stroke in previous three months prior to baseline testing.\n26. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.",{"count":144,"type":21},386,[84],"Lower extremity revascularization combined with supervised exercise significantly improves walking performance compared to revascularization alone in people who have PAD without limb threatening ischemia. However, supervised exercise is inaccessible or burdensome for most PAD patients. Investigators hypothesize that home-based exercise combined with lower extremity revascularization will significantly improve walking performance compared to revascularization alone in patients with PAD undergoing revascularization for disabling PAD.\n\nInvestigators further hypothesize that inorganic nitrate, a major source of nitric oxide (NO) abundant in beetroot juice, will improve walking performance after lower extremity revascularization, compared to placebo. In preclinical models, NO inhibits inflammation, neointimal hyperplasia, thrombosis, and vascular smooth muscle cell migration at sites of revascularization. NO increases angiogenesis and perfusion, repairs skeletal muscle damaged by ischemia, and stimulates mitochondrial activity.\n\nIn a randomized clinical trial with a 2 x 2 factorial design, the trial will test the following two primary hypotheses in 386 patients randomized within three months of a successful lower extremity revascularization for disabling PAD: First, that home-based exercise combined with lower extremity revascularization will improve six-minute walk distance more than revascularization alone at 6-month follow-up (Primary Aim #1). Second, that nitrate-rich beetroot juice combined with lower extremity revascularization will improve six-minute walk, compared to placebo combined with revascularization at 6-month follow-up (Primary Aim #2).",[117,28,148,149,150],"Peripheral Vascular Disease","Mobility Limitation","Revascularization",[152,153,154,150,88,155,156,157],"Behavior Change","Patient Reported Outcome Measures","Mobility","Intermittent claudication","6-minute walk","Oxidative stress","2025-08-23",{"date":160,"type":36},"2025-08-26",{"date":162,"type":36},"2025-08-04",{"date":164,"type":21},"2032-08-01",{"name":166,"class":43},"Northwestern University",7,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":17,"minAge":176,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":54,"phases":178,"briefSummary":180,"conditions":181,"keywords":184,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},"100566653","phase-2-response-to-exercise-and-nitric-oxide-in-pad-100566653","NCT06657976","Response to Exercise and Nitric Oxide in PAD","Response to Exercise and Nitric Oxide in Peripheral Artery Disease: The RESIST PAD Trial","RESIST","Inclusion Criteria:\n\n1. An ABI less than or equal to 0.90 at baseline.\n2. Vascular lab evidence of PAD (such as a toe brachial pressure less than or equal to 0.70 or an ankle brachial index less than or equal to 0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities.\n3. An ABI of more than 0.90 and less than 1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test.\n\nExclusion Criteria:\n\n1. Above- or below-knee amputation\n2. Limb-threatening ischemia defined as an ABI less than 0.40 with symptoms of rest pain\n3. Wheelchair confinement or requiring a walker to ambulate\n4. Walking is limited by a condition other than PAD\n5. Current foot ulcer on bottom of foot\n6. Failure to complete study-run\n7. Unwilling to accept randomization into either group (supervised exercise or attention control)\n8. Planning to engage in new walking exercise outside of the study or unwilling to refrain from new walking exercise activity during the trial.\n9. Already exercising at a level consistent with exercise intervention, using investigator discretion.\n10. End-stage kidney disease (ESKD) that is treated with hemodialysis.\n11. Planned major surgery, coronary or leg revascularization during the next six months\n12. Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months\n13. Major medical illness including lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. \\[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who require oxygen only at night may still qualify.\\]\n14. Mini-Mental Status Examination (MMSE) score less than 23 or dementia. If the MMSE is less than 23 and the Principal Investigator evaluation determines that the lower score is related to language barriers or education level, the Principal Investigator has discretion to allow a participant with MMSE less than 23 to participate, as appropriate. Dementia with sufficient impairment to prevent full engagement in all aspects of the trial will be an exclusion per the investigator's discretion.\n15. Allergy to beetroot juice\n16. Currently consuming beetroot juice, oral nitrate or nitrite, or a beetroot supplement and\u002For unwilling to avoid beetroot juice during the study. Participants will be asked to discontinue these items for 30 days before baseline testing and throughout the clinical trial. If the potential participant is unwilling to refrain from taking these items, they will not be eligible for the clinical trial.\n17. Currently consuming one cup or more of beets daily. Participants will be asked to discontinue beet ingestion of one cup or more of beets for 30 days before baseline testing and throughout the clinical trial. If the potential participant is unwilling to refrain from daily beet consumption of one cup or more for 30 days before the trial and during the trial, they will not be eligible for the clinical trial.\n18. Unstable angina\n19. Abnormal baseline stress test without subsequent clearance for exercise by physician\n20. Non-English speaking. The RESIST PAD interventions are delivered by interventionists who do not speak non-English languages. The integrity of the clinical trial requires clear and effective communication for data collection and intervention delivery. The trial does not have staff members who are fluent in non-English languages nor does it have the ability to translate all study materials into other languages.\n21. Participation in or completion of a clinical trial in the previous three months. \\[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\\] Participants in a study that involved up to three single doses of nitrate-rich beetroot juice administered on separate days may participate if a month has passed since their last dose of nitrate-rich beetroot juice.\n22. Visual impairment that limits walking ability.\n23. Baseline blood pressure less than 100\u002F45.\n24. Participation in a supervised treadmill exercise program in previous three months or planning to begin a supervised treadmill exercise program in the next six months.\n25. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.","50 Years",{"count":82,"type":21},[179],"PHASE2","RESIST PAD is a randomized trial of 200 PAD patients to establish: 1) whether a 12-week exercise intervention significantly increases Δ nitrite at 12-week follow-up, compared to control; 2) whether exercise \"responders\" have greater Δ nitrite increases compared to \"non-responders\"; 3) among non-responders, whether supplementing exercise with nitrate-rich beetroot juice between weeks 13-24 increases Δ nitrite and improves 6-minute walk at 24-week follow-up.",[117,182,28,183],"Exercise","Nitric Oxide",[88,185,186],"Claudication","Walking difficulty","2025-07-09",{"date":189,"type":36},"2025-07-11",{"date":191,"type":36},"2025-01-23",{"date":193,"type":21},"2029-10-01",{"name":166,"class":43},2,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":203,"minAge":18,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":54,"phases":206,"briefSummary":207,"conditions":208,"keywords":209,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100547634","personalised-multicomponent-exercise-programme-in-peripheral-arterial-disease-100547634","NCT06410521","Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease","Personalisation of Non-surgical Treatment in Peripheral Arterial Disease Using a Multicomponent Exercise Approach","Inclusion Criteria:\n\n* Diagnosed with clinically stable PAD;\n* An ankle-brachial index (ABI) between 0.41-0.90 at rest in one or both lower limbs;\n* Mild to moderate claudication, corresponding to Fontaine Stage IIa and IIb;\n* A history of ambulatory leg pain;\n* Ambulatory leg pain confirmed by treadmill test;\n* Able to provide written consent.\n\nExclusion Criteria:\n\n* Noncompressible, calcified, tibial arteries (resting ABI ≥ 1.4);\n* Use of medication that could influence claudication (e.g. Cilostazol or Pentoxifylline) 3 months prior to investigation;\n* Previous intervention (e.g. balloon angioplasty, stenting, bypass, exercise programme);\n* Inability to walk on a treadmill at a speed of 3.2 km\u002Fh (2 mph);\n* Participation in the past 3 months in a clinical trial or exercise program;\n* Asymptomatic PAD determined from the medical history;\n* Exercise limited by factors other diseases or conditions than intermittent claudication;\n* Angina pectoris, congestive heart failure, chronic obstructive pulmonary disease, severe arthritis, or limb amputation.","MALE",{"count":205,"type":21},40,[56],"Peripheral arterial disease (PAD) is characterised as an atherosclerotic disease, most common in the lower limbs (aortoiliac, femoropopliteal, and infrapopliteal arterial segments), which causes a decrease in blood flow to the areas adjacent to and posterior to the affected area. Intermittent claudication (IC) is the most common symptom in this disease that appears with exertion and relieves with rest, causing fatigue, cramps, discomfort, or pain in the lower limbs due to limited blood flow to the affected muscles. Supervised physical exercise has emerged as the first line of intervention in improving the symptoms of intermittent claudication and disease progression, and in the last decade there has been an exponential increase in the use of wearable technologies to monitor dose-response. However, the approach used is still simplistic because it is not personalised. In other words, patients with similar diagnoses and symptoms get the same treatment, without personalising the stimulus according to their exercise responses and level of adaptation. With this in mind, this study aims to monitoring the real-time response of a multicomponent exercise programme (cardiovascular and resistance training) to personalise the dose-response, and use artificial intelligence models to gather and analyse vast amounts of data towards grouping\u002Fdifferentiating based on individual responses. The main hypothesis is that a supervised multicomponent exercise programme will improve the functional capacity of patients with PAD in a cluster personalised approach.",[25,28],[210,211],"Peripheral arterial disease","Supervised multicomponent exercise programme","2025-06-24",{"date":214,"type":36},"2025-06-27",{"date":216,"type":36},"2025-06-20",{"date":218,"type":21},"2027-12",{"name":220,"class":43},"University of Trás-os-Montes and Alto Douro",3,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":54,"phases":232,"briefSummary":233,"conditions":234,"keywords":235,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":44},"100539139","supervised-exercise-based-rehabilitation-for-people-with-intermittent-claudication-in-denmark-100539139","NCT06299956","Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark","Supervised Exercise-based Rehabilitation for People With Intermittent Claudication - Study Protocol for a Danish Implementation Process (StRiDE).","StRiDE","Inclusion criteria:\n\n* Relevant symptoms of intermittent claudication; leg pain when walking due to arteriosclerosis and relieve of symptoms during rest.\n* Distal blood pressure with an ankle-brachial index (ABI) \\> 50 mmHg for non-diabetics or toe brachial index (TBI) \\> 40 mmHg for diabetics.\n\nExclusion criteria:\n\n• Evaluated by a vascular surgeon: patients with contraindications e.g. medical issues or comorbidity that enables a participation in SET are not referred.",{"count":231,"type":21},600,[56],"The goal of this project is to implement a protocol for a supervised exercise therapy intervention including smoking cessation in the municipalities in region Zealand in Denmark. The participants are adults with intermittent claudication.\n\nThe objective of this project is to describe:\n\n1. The development and design of the implementation process of a rehabilitative intervention including SET and smoking cessation in Region Zealand with a 6-month follow-up period after completion of the SET.\n2. The ongoing quality monitoring process of the implementation in terms of referral, recruitment, retention, data completeness, intervention delivery and attendance and to collect feedback that will guide refinements of the intervention delivery and data collection.\n3. Outcomes available for assessment of benefits and harms from the SET intervention.\n\nParticipants will be asked to do supervised exercise therapy by walking on a treadmill for 3 times a week for 12 weeks, and engage in smoking cessation, if they are smoking.",[28],[236,237,238,239,240,241],"Exercise therapy","Smoking cessation","Implementation","Stakeholders","Walking","Treadmill","2025-05-20",{"date":244,"type":36},"2025-05-25",{"date":246,"type":36},"2023-09-01",{"date":248,"type":21},"2029-01",{"name":250,"class":43},"Slagelse Hospital",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":54,"phases":260,"briefSummary":261,"conditions":262,"keywords":266,"overallStatus":271,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":44},"100579699","heat-therapy-and-peripheral-artery-disease-100579699","NCT06827691","Heat Therapy and Peripheral Artery Disease","Heat Therapy for People with Peripheral Artery Disease: a Randomised Wait-List Controlled Feasibility Trial.","Inclusion Criteria:\n\n* • Aged \\> 18 years\n\n  * ABPI \\\u003C 0.9 at rest or a drop of 20mmHG after exercise testing\n  * Diagnosed with IC\n  * Able to walk unaided\n  * English-speaking and able to follow instructions\n  * No previous history of heat syncope\n  * Post-Menopausal or not on hormone therapy\n  * Able to provide informed consent\n\nExclusion Criteria:\n\n* • Walking impairment for a reason other than PAD\n\n  * Critical limb ischaemia\u002Frest pain\n  * Asymptomatic PAD\n  * Active cancer treatment\n  * Clinically diagnosed diabetes or those with peripheral neuropathy\n  * Recent \u002F frequent heat exposure (e.g., sauna or hot tubs).\n  * severe aortic stenosis, unstable angina, recent MI, stroke or TIA",{"count":259,"type":21},70,[56],"The purpose of the study is to assess the efficacy of a novel 8 week heat therapy intervention in intermittent claudication compared to usual care controls. Participants will be enrolled on a wait-list control randomised trial testing physiological, mechanistic, and health related outcome measures.",[25,263,264,28,265],"Cardiovascular Health","Vascular Function","Peripheral Vascular Diseases",[267,268,269,270],"heat therapy","cardiovascular health","endothelial function","heat intervention","NOT_YET_RECRUITING","2025-02-10",{"date":274,"type":36},"2025-02-14",{"date":276,"type":21},"2025-05-01",{"date":278,"type":21},"2028-01-01",{"name":280,"class":43},"Manchester Metropolitan University",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":54,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":44},"100474425","home-based-exercice-therapy-for-patients-with-intermittent-claudication-using-a-new-smartphone-application-100474425","NCT05457738","Home-based Exercice Therapy for Patients With Intermittent Claudication Using a New Smartphone Application","Home-based Exercice Therapy for Patients With Intermittent Claudication Using a New Smartphone Application : a Monocentric Randomized Study","APAISE","inclusion criteria :\n\n* \\- Patient over 18 years old\n* Patient with claudication on PAD for more than 3 months\n* IPS (systolic pressure index) less than 0.90 at the level of the diseased limb\n* Absence of pathology limiting walk other than PAD\n* Patient having benefited from an arterial ultrasound of the lower limbs demonstrating arterial lesion\n* Absence of myocardial infarction over the last 6 months\n* Absence of cardiac pathology requiring surgery\n* Absence of angina\n* Patient affiliated or entitled to a social security system\n* Patient having given his free and written consent\n\nexclusion criteria :\n\n* Patient who has not benefited from an arterial ultrasound of the lower limbs\n* All contraindications to treadmill events:\n\n  * Myocardial infarction within the last 6 months\n  * angina\n  * Symptomatic tight aortic valve stenosis\n  * Pathology limiting walk other than PAD",{"count":290,"type":21},52,[56],"The main characteristic of PAD is to limit physical activity by the appearance of claudication of the lower limbs which limits the walking distance, or the maximum distance traveled by the patient before the pain forces to stop. In daily practice, the walking distance is rarely measured at the time of treatment.\n\nWalking rehabilitation is the first-line treatment for these patients (class 1 recommendation from the AHA 2005 and the ESC 2017 with level A evidence). According to the recommendation, a walking session must last at least 30 minutes at the rate of 3 sessions per week for a minimum of 6 months.\n\nWalking rehabilitation should be systematically offered to all claudicating patients, whether operated on or not. It is often sufficient for mild claudication with a walking distance of more than 500 meters. Surgery should be reserved for patients in whom rehabilitation has failed and in whom the claudication is severe (walking distance less than 500 meters). Surgical intervention should not replace rehabilitation, but should be complementary.\n\nSupervised rehabilitation in specialized centers is rarely offered because it is not easily available and involves additional expenses and constraints for the patient (transport, fewer work periods for active patients, etc.). In the absence of specialized center, simple advice is most often given to the patient, who then only has to rely on his personal motivation: this is the so-called \"go home and walk\".\n\nTherefore, access to well-conducted rehabilitation is a fundamental element of the management of patients with intermittent claudication, which is currently lacking. In the age of digital health, it is necessary to develop innovative tools allowing self-rehabilitation of the patient in addition with remote monitoring by the doctor.\n\nRecent studies have validated and highlighted the interest of using GPS technology for the evaluation of walking activity in claudicants. To date, there are 2 published examples of smartphone applications developed specifically for exercise rehabilitation. The main shortcomings of the solutions proposed in these publications are:\n\n* The need to buy a specific GPS box\n* Discomfort for the patient to carry the box either in a backpack or over the shoulder\n* The lack of means for the patient to indicate the precise moment when the pain appears\n* And consequently the absence of clinical analysis centered on the symptom \"walk induced pain\" Consumer smartphone applications for GPS activity tracking are not intended for medical use and do not indicate when pain occurs.\n\nIn this study, the University Hospital of REIMS will establish a scientific collaboration with the company VascInnove® for the use of a smartphone application, called E-REVA® which offers:\n\n* an assessment of walking activity and claudication parameters (appearance of pain, walking distance, recovery time after pain, total distance travelled, walking speed, etc.)\n* help with self-rehabilitation\n* quality of life and walking questionnaires\n\nThe main innovation is the presence of a button allowing the patient to indicate when the pain appears. The patient will be able to have access via the smartphone application to his statistics and the evolution of his performance over time. The prescribing practitioner will have access, via a secure website, to the statistics of his patient, to whom he will be able to give personalized advice during follow-up consultations.\n\nThe aim of this study is to carry out a single-centre prospective randomized stratified study (depending on whether or not patient has been revascularized) in patients with intermittent claudication who will or will not use the rehabilitation assistance smartphone application, seen in consultation for vascular surgery and vascular medicine at the University Hospital of Reims.",[28],[155,295,296,297,298],"peripheral arterial disease","supervised exercise therapy","home-based exercise","smartphone medical application","2025-01-17",{"date":301,"type":36},"2025-01-20",{"date":303,"type":36},"2024-04-19",{"date":305,"type":21},"2028-05-19",{"name":307,"class":43},"CHU de Reims"]