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Critical Limb Ischemia clinical trials

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NCT ID: NCT06318767 Recruiting - Clinical trials for Peripheral Artery Disease

Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) in Peripheral Artery Disease (PAD) at Critical Ischaemia Stage

TAMIS
Start date: March 4, 2024
Phase: N/A
Study type: Interventional

Peripheral artery disease (PAD), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades. It has various symptoms ranging from mild arterial claudication to critical limb ischemia. The critical ischaemia stage in PAD is defined by rest pain or trophic disorders and is a special situation because of the number of cardiovascular deaths at 1 year (25%), 60% at 5 years and acute ischaemic recurrence at 1 year (25%). It is a medico-surgical pathology. A haemodynamic marker is needed to monitor patients, as it is predictive of limb progression, cardiovascular events and mortality. The Systolic Rise Time (SRT) of the plantar footpad is a recently described haemodynamic measurement of proven value in the diagnosis of PAD. The aim of this study is to show the prognostic value of the Systolic Rise Time on Major Adverse Limb Events (MALE).

NCT ID: NCT06296576 Not yet recruiting - Clinical trials for Critical Limb Ischemia

Acceleration Time Assessment for Prediction of Critical Limb Ischemia

ATACLI
Start date: March 1, 2024
Phase:
Study type: Observational

Critical Limb Ischaemia (CLI), the final stage of arterial disease, is a therapeutic emergency whose prognosis depends largely on the time taken to diagnose it. The growing prevalence of this condition and the associated healthcare costs make it an important public health objective. Diagnostic criteria for Critical Limb Ischaemia differ between learned societies and countries. Its diagnosis is most frequently based on the combination of a clinical criterion (ischaemic decubitus pain and/or necrotic wounds, with a time to onset > 2 weeks) and a haemodynamic criterion (ankle systolic pressure (ASP) < 50mmHg or toe systolic pressure (TSP) < 30 mmHg or transcutaneous oxygen pressure (TCPO2) < 30 mmHg). Recent studies have highlighted the importance of pulsed Doppler flow analysis in quantifying arteriopathy of the lower limbs, both by systematically analysing flow modulation and by measuring the systolic rise time of distal arteries (dorsal artery of the foot and lateral plantar artery). The main aim of our study is therefore to validate a reliable and accessible diagnostic tool for screening patients suffering from CLI so that they can be referred to a reference centre as early as possible.

NCT ID: NCT06204237 Recruiting - Clinical trials for Critical Limb Ischemia

Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC in Subjects With PAOD/CLI and Healthy Volunteers (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET/CT = Positron Emission Tomography/Computed Tomography)

CHASE
Start date: February 1, 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this Phase 0 clinical trial is to evaluate safety and biodistribution of [89Zr]Zr-DFO-APAC in patients with peripheral arterial occlusive disease / critical limb ischemia (PAOD/CLI) and healthy volunteers. The main questions it aims to answer are: - What is the safety, tolerability and pharmacokinetic profile (PK: both systemic and local vascular injury site-specific PK) of [89Zr]Zr-DFO-APAC? - What is the biodistribution and internal radiation dosimetry of the tracer dose of [89Zr]Zr-DFO-APAC? - What is the binding and retention time of [89Zr]Zr-DFO-APAC to arteries and atherosclerotic or microvascular lesions? Participants will receive a dose of the [89Zr]Zr-DFO-APAC (IMP) and PET/CT imaging is performed on days 1, 3 and 7, and follow-up visit 7-14 days post IMP dosing.

NCT ID: NCT06191237 Not yet recruiting - Clinical trials for Critical Limb Ischemia

Effect of Environmental Temperature on Vascular Ultrasound Vein Scan Measurements

Start date: February 1, 2024
Phase:
Study type: Observational

We wish to conduct two vascular ultrasound scans conducting vein measurements in two separate scanning rooms to assess if environmental temperature affects the vein diameter recorded.

NCT ID: NCT06186505 Not yet recruiting - Clinical trials for Peripheral Arterial Disease

Heat Therapy for Peripheral Arterial Disease (HEATPAD)

HEATPAD
Start date: January 1, 2025
Phase: N/A
Study type: Interventional

Peripheral arterial disease (PAD) is a disabling condition, with symptoms of muscle cramping or pain on exertion, which can substantially reduce quality of life. This study aims to see if AirGlove device improves participants circulation. This is phase 1 study and will be taken in 3 parts: Phase 1a will be undertaken in 10 healthy volunteers to assess the effects of the AirGlove device on lower limb arterial flow, tissue perfusion, quality of life and product usability following a single session. Phase 1b will be undertaken in 20 participants with intermittent claudication to assess the effects of the AirGlove device on lower limb arterial flow, tissue perfusion, quality of life and product usability both in a single session and following a 12-week trial of heat therapy. Phase 1c will be undertaken in 10 participants with critical limb ischaemia Rutherford stage 4 (rest pain). Lower limb arterial flow, tissue perfusion, pain scores, quality of life, and product usability will be assessed both in a single session and following a 2-12 week trial of heat therapy.

NCT ID: NCT06174597 Recruiting - Clinical trials for Critical Limb Ischemia

Umbilical Cord Artery-derived Perivascular Stem Cells for the Critical Limb Ischemia Therapy

Start date: June 30, 2023
Phase: Early Phase 1
Study type: Interventional

This clinical trial included 2 periods. During the first period, it was a single arm study to explore the safety of umbilical cord artery-derived stem cells (UCA-PSCs) in the treatment of patients with critical limb ischemia (CLI). During the second perid, it was a single-center, randomized, controlled prospective study to determine the efficacy of the UCA-PSCs treatment. Those who had CLI were enrolled in the study.

NCT ID: NCT06122974 Not yet recruiting - Clinical trials for Critical Limb Ischemia

Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia

DEEPER RCT
Start date: January 2024
Phase: N/A
Study type: Interventional

The purpose of this trial is to evaluate the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA. The Drug Eluting Temporary Spur Stent System is intended for use as a primary treatment in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.

NCT ID: NCT06075940 Not yet recruiting - Clinical trials for Critical Limb Ischemia

Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in the Treatment of Patients With Below the Knee Disease in Australia

MAGNITUDE-BTK
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The objective of this prospective, multi-center, clinical investigation is to evaluate the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Up to 30 subjects will be enrolled at approximately 3 clinical sites in Australia.

NCT ID: NCT06066268 Recruiting - Clinical trials for Critical Limb Ischemia

miRNAs in Critical Limb Ischemia (miRNACLI)

miRNACLI
Start date: May 31, 2016
Phase:
Study type: Observational

For the present study, 40 patients affected by critical limb ischemia of different severity will be enrolled: patients affected by critical limb ischemia undergoing subgenual femoropopliteal bypass; patients suffering from terminal ischemia causing gangrene and therefore undergoing major amputation of the lower limb. Biopsies from the first 20 enrolled patients will be used for miRNA profiling. The total of 40 biopsies obtained from all enrolled patients will instead be used for the validation of the miRNAs identified in the profiling. The results obtained will be compared with those obtained in 40 control patients affected by infrarenal abdominal aortic aneurysm (AAA) undergoing endovascular exclusion surgery (EVAR) of the AAA without any ischemia of the lower limbs. Also in this case the biopsies of the first 20 control patients enrolled will be used for miRNA profiling. The total of 40 biopsies obtained from all control patients will instead be used for the validation of the miRNAs identified in the profiling. A total of 80 patients (40 cases and 40 controls) will be enrolled.

NCT ID: NCT06007469 Not yet recruiting - Clinical trials for Critical Limb Ischemia

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

PAT
Start date: October 4, 2023
Phase:
Study type: Observational [Patient Registry]

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.