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Critical Limb Ischemia clinical trials

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NCT ID: NCT06434194 Not yet recruiting - Clinical trials for Critical Limb Ischemia

Serrantor OCT Study

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.

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

Effect of Environmental Temperature on Vascular Ultrasound Vein Scan Measurements

Start date: May 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: 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: June 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: 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.

NCT ID: NCT04974905 Not yet recruiting - Clinical trials for Critical Limb Ischemia

Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

The spectrum of lower extremity peripheral arterial disease (PAD) ranges from exhibiting no symptoms to limb threatening gangrene. The number of patients living with it is rising steadily owing to increased life expectancy, obesity, diabetes, and tobacco consumption. Critical limb ischemia (CLI) is the terminal and the most serious stage of PAD in which blood flow to the lower extremity does not meet metabolic demands of the tissues at rest. The diagnosis is mainly clinical and patients are presented with rest pain, minimal tissue loss or frank gangrene. Revascularization strategies include endovascular procedures and surgical bypass.Endovascular therapy has evolved as an attractive, minimally invasive method of revascularization especially in the more frequently encountered patients with medical and anatomical contraindications to surgical revascularization. Antegrade approach is the standard approach in infrainguinal arterial occlusive disease,however, failure occurs in about 20% of infrainguinal attempts.Retrograde approach is used as a backup technique in failed cases.

NCT ID: NCT04433572 Not yet recruiting - Clinical trials for Peripheral Artery Disease

Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee

TANGO-3
Start date: December 1, 2020
Phase: Phase 3
Study type: Interventional

A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the incidence of ischemia-driven major amputation, clinically driven target lesion revascularization, and clinically relevant target lesion occlusion after revascularization of lesions below the knee in patients with symptomatic Rutherford 3-5 peripheral artery disease. The primary safety endpoint will be gathered at 1-month post-index procedure. The primary efficacy endpoint will be gathered at 6 months post-index procedure. Participants will be followed for up to 5 years post-index procedure.

NCT ID: NCT04427124 Not yet recruiting - Clinical trials for Peripheral Arterial Disease

The CLI-AMP Registry

CLI-AMP
Start date: August 1, 2020
Phase:
Study type: Observational [Patient Registry]

Single-center, observational registry study with a prospective and retrospective arm to evaluate the impact of multidisciplinary CLI teams and protocol on amputation rates, vascular studies, revascularization, in-hospital and long-term outcomes.

NCT ID: NCT04312555 Not yet recruiting - Clinical trials for Critical Limb Ischemia

Alprostadil as an Adjuvant Therapy With Indirect Angiosomal Revascularization in Critical Limb Ischemia.

Start date: April 1, 2020
Phase: Phase 4
Study type: Interventional

The aim of this study is to assess the efficacy of Alprostadil (Prostaglandin E2) as adjuvant therapy after failure of direct but indirect angiosomal revascularization in patients with critical limb ischemia.