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Optical Methods for Diabetic Foot Ulcer Screening
Published in Andrey V. Dunaev, Valery V. Tuchin, Biomedical Photonics for Diabetes Research, 2023
Robert Bartlett, Gennadi Saiko, Alexandre Yu. Douplik
SPP has been studied extensively in both diagnostic and prognostic capacities. It provides quantitative measurement to guide the need for revascularization and the probability of healing lower extremity ischemic ulcers, skin incisions, or amputation sites. The following observations are made in clinical practice [33–36]: <30 mmHg –critical limb ischemia30–40 mmHg –impaired wound healing based on perfusion40–50 mmHg –abnormal, impaired healing>50 mmHg –normal skin perfusion.
Overview of Development of Gene Therapy
Published in Yashwant V. Pathak, Gene Delivery Systems, 2022
Ofosua Adi-Dako, Doris Kumadoh, Yashwant V. Pathak, Nana Kwame Gyamerah
Subsequently by August 2019, four new gene therapy drugs were approved by the Japan Ministry of Health, Labour and Welfare (MHLW); FDA; and EMA, respectively: Collategene, a naked plasmid encoding human HGF gene, was developed for the treatment of critical limb ischemia (CLI) (Suda, Murakami, Kaga, Tomioka, & Morishita, 2014).Zolgensma (onasemnogene abeparvovec-xioi) is an a rAAV-based gene therapy drug indicated in pediatric patients with SMA and biallelic mutation in the survival motor neuron (SMN) 1 gene (Hoy, 2019).Waylivra (volanesorsen), an antisense oligonucleotide inhibitor of apolipoprotein CIII (apoCIII) mRNA, was used for the treatment of adult patients with familial chylomicronemia syndrome (Paik & Duggan, 2019).Zynteglo, a genetically modified autologous CD34+ cell-enriched population that contained HSCs modified with lentiviral vector encoding the βA-T87Q-globin gene, has been used for patients 12 years and older with transfusion-dependent β-thalassemia (Cavero, Seimetz, Koziel, Zimmermann, & Holzgrefe, 2020; Ma, Wang, Xu, He, & Wei, 2020).
Clinical Trials of Hematopoietic Stem Cells for Cardiac and Peripheral Vascular Diseases
Published in Richard K. Burt, Alberto M. Marmont, Stem Cell Therapy for Autoimmune Disease, 2019
Patients qualified for marrow implantation if they had chronic critical limb ischemia including rest pain and/or nonhealing ischemic ulcers and were not candidates for nonsurgical or surgical revascularization. Requisite hemodynamic deficits included a resting ankle-brachial pressure index (ABI) <0.6 in the affected limb on two consecutive examinations performed at least 1 week apart. Patients with poorly controlled diabetes mellitus (HbAlc>6.5 and proliferative retinopathy) or with evidence of malignant neoplasm (during last 5 years) were excluded. Patients (n=45) were treated on a multicenter, randomised, double-blind trial; BM-MNC (active treatment) or PB-MNC (control cells) were randomly, double-blindly implanted into right or left ischemic limbs. We used peripheral blood mononuclear cells (PB-MNC) as a more appropriate cell control than saline, since peripheral blood was partially contaminated during marrow aspiration procedure (-10% of marrow cells) and the number of CD34+ cells including EPC was ~500-fold less in PB-MNC than that in BM-MNC.
The FlowOx device for the treatment of peripheral artery disease: current status and future prospects
Published in Expert Review of Medical Devices, 2021
In peripheral artery disease (PAD), arterial blood flow to the extremities is impeded. Clinically, the severity of PAD ranges from asymptomatic disease to intermittent claudication or atypical extremity pain during exercise, and to critical limb ischemia characterized by rest-pain, tissue loss, and gangrene. Patients with PAD have an increased risk of cardiovascular morbidity and mortality, and the treatment strategy consists of cardiovascular risk modifying treatments, and treatment of leg symptoms. Exposure of the affected leg to cyclic pressure changes increases the macro- and microcirculatory blood flow and may be used for the treatment of PAD [1,2]. The principles of this treatment have been described since he early 20th century, however, has more recently become a treatment option for selected patients, as a new treatment device has been developed [3–5].
Safety and efficacy of paclitaxel drug-coated balloon in femoropopliteal in-stent restenosis
Published in Expert Review of Medical Devices, 2020
Mahesh Anantha-Narayanan, Keith Love, Sameer Nagpal, Azfar Bilal Sheikh, Christopher J. Regan, Carlos Mena-Hurtado
Peripheral arterial disease (PAD) is a progressive disorder that is characterized by stenosis and/or occlusion of medium and large sized non-coronary or cerebral arteries. With global epidemiologic transition toward non-communicable diseases and aging of the world population, PAD is becoming a more prevalent and morbid pathology [1]. The main risk factors of tobacco use, diabetes mellitus, and hyperlipidemia are similar to cardiovascular disease and common in the general population [2]. Within PAD, the femoropopliteal (FP) artery is a frequent site of disease and can result in claudication or critical limb ischemia (CLI) including rest pain or non-healing lower extremity wounds.
Device profile of the tack endovascular system® for the treatment of peripheral arterial disease: overview of safety and efficacy
Published in Expert Review of Medical Devices, 2021
Mark Vanderland, Yinn Shaung Ooi, William A. Gray
Approximately 6.5 million people over the age of 40 suffer from PAD in the United States of America [1] and it is estimated that PAD effects over 200 million people worldwide [2]. The incidence of PAD is expected to increase over time as a result of the aging population and the diabetic pandemic. The signs and symptoms of PAD are variable and can range from asymptomatic to lifestyle limiting claudication. A minority of these patients progress to critical limb ischemia, with devasting results. The management of PAD is complex and involves a multimodal approach including risk factor modification, medical therapy, supervised exercise therapy, endovascular intervention and surgical revascularization. Risk factor modification consists of smoking cessation and aggressive glucose control in diabetic patients with PAD [3]. Current guidelines recommend antiplatelet therapy, statin therapy, and blood pressure control to reduce the risk of myocardial infarction, stroke and vascular death in patients with symptomatic PAD. Cilostazol can be used in patients with claudication to improve symptoms and increase total walking distance. Supervised exercise programs are an important part of care for patients with PAD and have been shown to improve functional status, quality of life, and reduce claudication. Revascularization is usually considered when patients continue to suffer from claudication despite these more conservative measures. Since only a minority of patients with refractory claudication will go on to develop critical limb ischemia, the goal of revascularization in these patients is not limb salvage but rather to improve symptoms and functional status. Several revascularization strategies may be utilized in isolation or in combination with one another, including surgical revascularization and endovascular intervention with either stenting or balloon angioplasty.