Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05921461
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2023-05-10
Brief Title:
The Use of HOVR Technology for Assessment of Blood Associated Parameters
Sponsor:
Votis Subdermal Imaging Technologies LTD
Organization:
Votis Subdermal Imaging Technologies LTD
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 71000 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 testdevice 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
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 71000 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 testdevice 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None