The Use of HOVR Technology for Assessment of Blood Associated Parameters

NCT ID: NCT05921461

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-03-16

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.

Conditions

Peripheral Arterial Disease; Diabetes Mellitus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control NON-PAD

Measurement using the VOTIS PedCheck system

No interventions assigned to this group

PAD patients

Measurement using the VOTIS PedCheck system

No interventions assigned to this group

Eligibility Criteria

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.

• Good health according to self-report

• 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

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.

• 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

• 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: collaborator

Votis Subdermal Imaging Technologies LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hamutal Shahar, PhD

Role: STUDY_DIRECTOR

Votis Subdermal Imaging Technologies

Locations

Hadassah University Medical Center

Jerusalem, , Israel

Countries

Israel

Other Identifiers

PedCheck-V1-2.1

Identifier Type: -

Identifier Source: org_study_id