Track topics on Twitter Track topics that are important to you
There have not been any published studies showing the use of topical nitroglycerin on the dilatory effect on the posterior tibial or dorsalis pedis arteries. The objective of this study is to determine the response of the posterior tibial artery and dorsalis pedis artery to topical administration of nitroglycerin. This study may provide further information for the utility of this artery in the treatment of peripheral arterial disease.
This will be a prospective, randomized, blinded, placebo-controlled study to gather data on the effect of nitroglycerin on the pedal artery of patients with varying comorbidities. Patients will be divided into a treatment group and a control group. A detailed history will be taken from the patient to ascertain risk factors such as Hypertension, Hyperlipidemia, CAD, PAD, Tobacco abuse, Diabetes Mellitus, Family history of CAD/PAD, or history of non-healing wounds. Further demographic data such as sex, age, height, weight, body surface area, and body mass index will be documented.
Ultrasound measurements of the dorsalis pedis and anterior tibial artery will be obtained at baseline. Measurements will be obtained in the perpendicular plane using B mode on the vascular ultrasound. The largest diameter will be documented. Measurement of the largest intima diameter will be obtainedThe image will be temporarily stored for measurement purposes but will not be saved. The patients will then have differing treatments based on their groupings into the control or treatments arms.
Patient history, demographics and artery measurements will be kept on a password protected document and assigned a research patient identifier number. Another password protected document will contain the patient's name and patient identifier number. Only the principal investigator and sub-principal investigators will have access to these documents.
Patients in the control group will have measurements of their posterior tibial artery or dorsalis pedis artery bilaterally. The sites of evaluation will be marked with a surgical marker. A topical moisturizer will be placed 1 cm proximal to the measured areas of the leg and covered with a dressing bilaterally. Measurements of the arteries will be made at baseline, 10 minutes, 30 minutes, 60 minutes, and 90 minutes. In addition, non-invasive Blood Pressure measurements will be made at baseline, 10 minutes, 30 minutes, 60 minutes, and 90 minutes. The Moisturizer will be removed at 60 minutes bilaterally.
Patients in the treatment group will again receive measurements of the posterior tibial and dorsalis pedis arteries bilaterally which will be marked with a surgical marker. Randomly, the tibial artery or dorsalis artery will be selected and nitroglycerin paste will be placed 1 cm proximal to the measured area of one leg and moisturizer will be placed on the other leg in order create uniformity. Both legs will be covered with a dressing. These patients will randomly receive 15mg or 30mg of nitroglycerin. Bilateral measurements of the posterior tibial and dorsalis pedis arteries will be made at baseline, 10 minutes, 30 minutes, and 60 minutes, 90 minutes. In addition, non-invasive Blood Pressure measurements will be made at baseline, 10 minutes, 30 minutes, 60 minutes, and 90 minutes in the arm. The Moisturizer and nitroglycerin will be removed at 60 minutes.
Data handling and record keeping:
All data collected, including demographic information will be kept in the Cardiology research department, in a cabinet with lock and key. All electronic documents will be password protected and encrypted. Only the principal investigator and sub-principal investigators will have access to data.
Quality control and quality assurance:
The posterior tibial artery will initially be localized utilizing palpation starting at the level of the medial malleolus. Positioning will subsequently be confirmed by the use of ultrasound.
The Dorsalis Pedis artery will be localized utilizing palpitation starting at the level of the navicular bone. Positioning will subsequently be confirmed by the use of ultrasound.
When possible there will be an attempt to use measurements at the level of the anatomical landmark in order to provide standardization Any deviation will be documented.
Assessment of the Posterior Tibial and Dorsalis pedis arteries diameter and administration of nitroglycerin.
A Vascular ultrasound probe will be used to evaluate the diameter of the arteries. The same vascular probe will be used to evaluate each patient to ensure standard measurements. A horizontal and vertical diameter will be obtained to obtain an "Averaged diameter". Subsequently, the level measured will be marked to ensure rapid and accurate re-evaluation of the same area.
Nitroglycerin paste or moisturizer will be added to the treatment/control leg/artery depending on the arm of the study the patient is randomized to. It will be administered 1 cm above the site being evaluated. Measurements will be made at 30, 60, and 90 minutes.
Possible risks include hypotension (although this was not noted in prior studies using nitroglycerin in the radial artery), headache, rash, possible allergic reaction to any components.
The effects of nitroglycerin on dilatation and spasm of the radial artery has been previously documented. . As the pedal arteries become more widely used in the treatment of peripheral arterial disease, a quantification of the effects of nitroglycerin on the pedal arteries will be beneficial for its potential as an alternative or auxiliary access site in peripheral cases.
This study is exclusively for inpatients. The half-life of nitroglycerin is 30 minutes. As a result, 2.5 hours after the ointment has been removed, the nitroglycerin will be considered metabolized. During this time the patient will be closely monitored. Only one patient will be investigated at a time and the investigator initiating the study will be present on the medical floor for the duration of the entire examination.
Peripheral Arterial Disease
Nitroglycerin Topical Product
Not yet recruiting
Deborah Heart and Lung Center
Published on BioPortfolio: 2019-11-12T18:25:30-0500
The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX0503) to relieve Raynaud's symptoms and increase blo...
The radial artery, which is located on the outer side of the forearm, can be used in interventional procedures, such as cardiac catheterization, to provide access to the arterial blood sup...
The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX-503) to relieve Raynaud's symptoms and increase blo...
The purpose of this clinical study is to determine the response to two different dosage strengths of a topical nitroglycerin gel in patients with Raynaud's Phenomenon. Patient fingers wil...
The purpose of this study is to investigate the efficacy and safety of a topical gel formulation of nitroglycerin, in comparison to a matching placebo, for patients with moderate to severe...
To assess the feasibility of novel photoplethysmography (PPG) Pulse Sounder/Pulse Visualizer communication techniques for alerting the presence (or absence) of peripheral arterial disease (PAD).
Drug-coated balloons (DEB) and drug-eluting stents (DES) emerged as a tool to aid in lowering the rates of neointimal hyperplasia and target lesion restenosis following endovascular peripheral arteria...
Peripheral arterial disease has an important impact on morbidity/mortality. The objective of this study was to quantify the impact of this disease in Portugal during the last eight years, expressed b...
The purpose of this study was to examine the effects of a 12-week in-home self-monitored physical activity (PA) program targeting a combination of lifestyle physical activity program on changes in end...
The purpose of this study was the assessment of volumetric CT-perfusion (CTP) of the lower leg musculature in patients with symptomatic peripheral arterial disease (PAD) of the lower extremities, comp...
Regional infusion of drugs via an arterial catheter. Often a pump is used to impel the drug through the catheter. Used in therapy of cancer, upper gastrointestinal hemorrhage, infection, and peripheral vascular disease.
A respiratory stimulant that enhances respiration by acting as an agonist of peripheral chemoreceptors located on the carotid bodies. The drug increases arterial oxygen tension while decreasing arterial carbon dioxide tension in patients with chronic obstructive pulmonary disease. It may also prove useful in the treatment of nocturnal oxygen desaturation without impairing the quality of sleep.
Lack of perfusion in the EXTREMITIES resulting from atherosclerosis. It is characterized by INTERMITTENT CLAUDICATION, and an ANKLE BRACHIAL INDEX of 0.9 or less.
Thickening and loss of elasticity of the walls of medium and large muscular ARTERIES with lesions in the innermost layer of the artery (ARTERIAL INTIMA). This disease process of atherogenesis includes the retention of cholesterol-rich LIPOPROTEINS and their binding to PROTEOGLYCANS in the arterial intima, generation of proinflammatory molecules that recruit MACROPHAGES to the subendothelial space, formation of FOAM CELLS, and eventual calcification of the arterial wall. These arterial plaques (atheromas) contain CARBOHYDRATES; BLOOD; and CALCIUM.
Comparison of the BLOOD PRESSURE between the BRACHIAL ARTERY and the POSTERIOR TIBIAL ARTERY. It is a predictor of PERIPHERAL ARTERIAL DISEASE.