The Use of Hemodynamic Occlusive and Vascular Response (HOVR) Technology for the Measurement of Absorption of Light in Order to Derive Changes of Perfusion and Oxygen Levels in the Foot.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Severe adverse device effects or serious adverse events that are recorded using standard adverse event report forms
研究概览
简要总结
Feasibility, usability and safety clinical study that is aimed at testing of the non-invasive VOTIS PedCheck system for measurement of changes in absorption of light in order to derive changes in perfusion and oxygen levels in the foot.
详细描述
Introduction:
Peripheral Arterial Disease (PAD) affects 8-12 million people in the United States, and approximately 230 million worldwide. When linked with diabetes, PAD results in over 71,000 amputations annually.
Patients with PAD have decreased lower extremity arterial perfusion which is commonly referred to as "poor circulation." In most cases of PAD, atherosclerotic plaques narrow the arterial flow lumen which restricts blood flow to the distal extremity. This condition is characterized by progressive vessel obstructions, associated with cardiovascular (CV) events, including myocardial infarction (MI), stroke, limb ischemia, and CV death. Although PAD is a prevalent condition, it is still considered as an underdiagnosed manifestation of atherosclerosis. PAD is one of the most common vascular complications of diabetes, and can cause foot ischemia which is associated with non healing wounds, gangrene and amputations. At present there is no gold standard or test/device to identify, evaluate, and monitor the circulatory health of the foot in a reliable and precise way. In addition, calcification of blood vessels in patients with diabetes complicates the evaluation of perfusion in the foot. Since diabetes has reached epidemic proportions (60M people affected in Europe), there is an urgent need for additional measurement tools for assistance for the evaluation of PAD complications.
The current study is aimed at feasibility, usability and safety testing of the non-invasive VOTIS PedCheck system as an assessment tool of PAD. The protocol allows for 30 PAD patients and 30 self assessed healthy controls.
Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and Women
- •Subject must be willing and able to sign an Informed Consent form to participate in the clinical study.
排除标准
- •Pregnant and breastfeeding woman
- •Any severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for the purposes of this study.
- •Control group Inclusion Criteria:
- •Good health according to self-report
- •Control group exclusion Criteria:
- •History of diabetes and/or a cardiovascular disease according to self-report
- •History of heavy smoking (20 cigarettes a day) for at least one year during the last 5 years prior to consent
- •Family history of severe cardiovascular disease, i.e. sudden cardiac death below the age of 50, according to self-report
- •Use of anti-hypertension drugs
- •PAD group Inclusion Criteria:
- •Subjects who are suspected of having PAD and have undergone or are planned to undergo ABI testing within 60 days prior to or after ICF signature
- •PAD group exclusion Criteria:
- •Existence of a WIfI graded severe foot infection (Infection grade 3) or severe infection (Infection grade 4), i.e. local infection or general infection with signs of systemic inflammatory response syndrome.
- •Amputation or a surgical procedure on the foot during the last 2 weeks
结局指标
主要结局
Severe adverse device effects or serious adverse events that are recorded using standard adverse event report forms
时间窗: Through study completion, an average of 1 year.
Observation of adverse skin changes or tissue damage or reports of discomfort.
PedCheck parameters that demonstrate correlation between HOVR and Ankle Brachial Index (ABI) and Toe Brachial Index (TBI).
时间窗: Through study completion, an average of 1 year.
HOVR score 0-100. 0-40 being no PAD, 40-100 being increasingly severe PAD.
次要结局
- Evaluation of usability based on collected data using standard pain scoring questionnaires.(Through study completion, an average of 1 year.)
- Evaluation of usability based on collected data using standard convenience scoring questionnaires.(Through study completion, an average of 1 year.)