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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Severe adverse device effects or serious adverse events that are recorded using standard adverse event report forms
Timeframe: 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).
Timeframe: Through study completion, an average of 1 year.