Diabetes Mellitus, Peripheral Arterial Disease
Conditions
Brief summary
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.
Detailed description
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: * To assess the safety of the PedCheck device using HOVR technology * To calibrate the measurement of changes in absorption of light in order to derive relative perfusion and oxygen levels in the foot. * To compare between PAD and non-PAD populations using HOVR. Secondary objective: • To collect data regarding the usability of the PedCheck device. Description of investigational product: Votis PedCheck portable device comprises patches affixed to the foot with encased laser diodes and photodetector sensors that automatically measure absorption of the light. Via lightweight leads, the patches link to a central control and display device. In addition an inflatable blood pressure cuff is placed above the knee. The control device sets the inflation and deflation of the cuff according to the protocol.
Interventions
None listed
Sponsors
Hadassah Medical Organization
Votis Subdermal Imaging Technologies LTD
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Men and Women * Age \>40 * Subject must be willing and able to sign an Informed Consent form to participate in the clinical study.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe adverse device effects or serious adverse events that are recorded using standard adverse event report forms | 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). | Through study completion, an average of 1 year. | HOVR score 0-100. 0-40 being no PAD, 40-100 being increasingly severe PAD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of usability based on collected data using standard convenience scoring questionnaires. | Through study completion, an average of 1 year. | Usability will be evaluated by standard usability patient and operator questionnaires for scoring convenience. Convenience will be rated by numerical rating scale for scoring convenience 0-5 where 0 represents very hard and 5 very easy. |
| Evaluation of usability based on collected data using standard pain scoring questionnaires. | Through study completion, an average of 1 year. | Usability will be evaluated by Numerical rating scale for scoring pain. 0-10 where 0 represents no pain and 10 the most severe. |
Countries
Israel
Outcome results
None listed