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PAD clinical trials

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NCT ID: NCT03686228 Recruiting - Clinical trials for Critical Limb Ischemia

Treatment of No-option CLI by G-CSF-mobilized PB-MNC

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with no-option CLI. Forty no-option CLI patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. The control group will be treated by medication and supportive treatment. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication. Amputation free survival,Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months.

NCT ID: NCT03683628 Recruiting - Clinical trials for Intermittent Claudication

Treatment of Intermittent Claudication by G-CSF-mobilized PB-MNC

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with intermittent claudication. Forty PAD patients who presented with intermittent claudication will be randomized into 2 groups. The control group will be treated by medication and walking exercise 3 times/ week. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication and walking exercise 3 times/ week. Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months

NCT ID: NCT03668353 Recruiting - Clinical trials for Critical Limb Ischemia

Recombinant SeV-hFGF2/dF Injection for PAOD

Start date: September 5, 2018
Phase: Phase 1
Study type: Interventional

Lower extremity arteriosclerosis obliterans is due to the formation of atherosclerotic plaque in the lower extremities, resulting in the stenosis and occlusion of the artery, leading to chronic ischemia of the limbs. Although bypass surgery and angioplasty ( or interventional therapy ) are effective methods for vascular treatment in patients with PAD to revascularize, a significant proportion of patients with the arterial disease are not eligible for direct arterial surgery. Meanwhile, there are many patients who suffer from diffuse arterial disease or severe peripheral disease not suitable for interventional therapy. Stimulation of arteriogenesis( blood bypassing the occluded arteries through a large number of collateral vessels ) and angiogenesis ( generating new small blood vessels ) have become the focus of research. Our recombinant SeV-hFGF2/dF injection (R&D code BF30 ) uses the human basic fibroblast growth factor ( FGF2 ) gene to express the target protein FGF2 locally by intramuscular injection. The preparation can efficiently express FGF2 in infected cells and secrete it to the periphery and be fixed in the intercellular substance. Since FGF2 is in the upstream regulatory pathway of VEGF, HGF and other factors, it can regulate the coordinated expression of these cytokines related to the growth and function of new blood vessels, and finally, produce mature blood vessels. To evaluate the safety ( tolerance), pharmacokinetics (PK), biological activity, and immunogenicity of BF30 in patients with lower extremity arterial occlusive disease, and to explore clinical benefits. MAIN OBJECTIVE: To evaluate the safety ( tolerability ) of single-dose BF30 in patients with lower extremity arterial occlusive disease, and to provide evidence for the dose of subsequent clinical trials. Secondary objective: To explore the pharmacokinetics (PK), biological activity, the immunogenicity of BF30, and to initially explore clinical benefits.

NCT ID: NCT03590769 Completed - Clinical trials for Peripheral Arterial Disease

Arterial Imaging of Inflammation and Resolution After Endovascular Surgery

AIIRES
Start date: June 1, 2017
Phase: Phase 1
Study type: Interventional

This study evaluates the local inflammatory and resolution response of patients undergoing peripheral vascular intervention like an angioplasty of the superficial femoral artery (SFA) or popliteal artery, or stenting of the iliac artery or SFA, through the use of Positron emission tomography-magnetic resonance imaging (PET/MRI). PET/MRI will be performed prior to intervention, one day and one week after intervention.

NCT ID: NCT03516383 Withdrawn - PAD Clinical Trials

Pulse Wave Velocity Imaging in the Assessment of PAD

PWVi
Start date: June 2016
Phase:
Study type: Observational

The purpose of this study is to predict the outcome of peripheral revascularization surgery by use of a new technology developed by our team, Pulse Wave Velocity imaging (PWVI), which has the capability to detect pulse transit time (PTT), and pulse wave velocity (PWV). This PWVI will be compared against known gold standards pre and post lower extremity limb revascularization and used to evaluate outcomes. Specifically, is leg PWV different among those with or without PAD, and is leg PWV different among those who undergo revascularization surgery and those who do not? This study represents the first clinical pilot study of the device with the aim to expand study participant numbers in future research and to eventually develop a PAD screening tool. This would be the first of its kind ever described.

NCT ID: NCT03452293 Completed - PAD Clinical Trials

SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients

SUPERSUBII
Start date: March 7, 2018
Phase:
Study type: Observational

The study will evaluate the safety and efficacy of subintimal Supera stenting in complex de novo or re-occlusive CTO (TASC C-D) lesions in patients with CLI. This study will be performed based on a rigorous sample size calculation, which will allow us to have the statistical power to validate our conclusions and therefore establish the generalizability of this strategy.

NCT ID: NCT03358355 Completed - Clinical trials for Peripheral Arterial Disease

Unacylated Ghrelin to Improve FuncTioning in PAD: The GIFT Trial

GIFT
Start date: June 7, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The GIFT pilot study will investigate the optimal subcutaneous dose and safety of subcutaneously administered unacylated ghrelin in older people with peripheral artery disease (PAD).

NCT ID: NCT03208920 Completed - Clinical trials for Abdominal Aortic Aneurysm

Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair

Omega-EVAR
Start date: December 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if high-dose PUFA supplementation in patients undergoing EVAR for infra-renal AAA reduces the peri-operative inflammation.

NCT ID: NCT03157531 Completed - PAD Clinical Trials

Safety and Effectiveness of B-Laserâ„¢ in Subjects Affected With Infrainguinal PAD

Start date: September 6, 2017
Phase: N/A
Study type: Interventional

This is a prospective, single-arm, multi-center, international, open-label, clinical study.

NCT ID: NCT03135535 Completed - Diabetes Clinical Trials

Micro-mobile Foot Compression and Diabetic Foot

Start date: May 2, 2017
Phase: Phase 2
Study type: Interventional

Diabetic foot ulceration (DFU) is a common and largely preventable complication. While most of these ulcers can be treated successfully, some will persist and become infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic ulcers will require amputation of the affected limb.Prevention by identifying people at higher risk is the key for better clinical management of such patients. It is not uncommon for patients suffering from diabetes to have concomitant lower extremity edema or even venous insufficiency and they subsequently may benefit from graduated compression. However, because of the common association of peripheral arterial disease (PAD) in patients with diabetes, most clinicians are reluctant to apply compressive dressings in fear of exacerbating the symptoms of PAD and the possible resulting gangrene. A novel micro-mobile foot compression device named Footbeat (AVEX, Inc.) offers alternative means providing lower extremity compression. This device is portable and can be used in a standard diabetic shoes on daily basis, which in turn may improve venous blood and relief from concomitant lower extremity edema. In addition, potential improvement in lower extremity blood flow in response to regular foot compression, could improve balance, gait, skin perfusion, plantar sensation, and overall daily physical activities (e.g. number of taken steps per day, duration of standing, etc). The purpose of this study is to conduct an observational study with N=30 ambulatory patients with diabetes and loss of protective sensation to assess whether this micro-mobile foot compression device can help improving motor function, lower extremity perfusion, and vascular health.