An observational study in Peripheral Arterial Disease and Diabetes Mellitus, sponsored by Votis Subdermal Imaging Technologies LTD. Completed at 1 site in Israel. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by Votis Subdermal Imaging Technologies LTD · Observational
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.
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:
Secondary objective:
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 60 is below the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →This is the only study on the registry with Votis Subdermal Imaging Technologies LTD as lead sponsor.
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Study population will be composed of 2 cohorts-
Exclusion Criteria:
Control group Inclusion Criteria:
Control group exclusion Criteria:
PAD group Inclusion Criteria:
PAD group exclusion Criteria:
Measurement using the VOTIS PedCheck system
Measurement using the VOTIS PedCheck system
Severe adverse device effects or serious adverse events that are recorded using standard adverse event report forms
Observation of adverse skin changes or tissue damage or reports of discomfort.
Time frame: Through study completion, an average of 1 year.
PedCheck parameters that demonstrate correlation between HOVR and Ankle Brachial Index (ABI) and Toe Brachial Index (TBI).
HOVR score 0-100. 0-40 being no PAD, 40-100 being increasingly severe PAD.
Time frame: Through study completion, an average of 1 year.
Evaluation of usability based on collected data using standard convenience scoring questionnaires.
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.
Time frame: Through study completion, an average of 1 year.
Evaluation of usability based on collected data using standard pain scoring questionnaires.
Usability will be evaluated by Numerical rating scale for scoring pain. 0-10 where 0 represents no pain and 10 the most severe.
Time frame: Through study completion, an average of 1 year.
Plan to share: No
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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