Peripheral Arterial DiseaseNCT05921461
The Use of HOVR Technology for Assessment of Blood Associated Parameters
An observational study of Peripheral Arterial Disease and Diabetes Mellitus, run by Votis Subdermal Imaging Technologies LTD at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease, Diabetes Mellitus
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2022to 16 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population will be composed of 2 cohorts- * Control cohort - Up to 30 healthy non-PAD subjects * PAD cohort - Up to 30 PAD patients diagnosed with Peripheral Arterial Disease (PAD)
Who may be able to join
- Men and Women
- Age >40
- Subject must be willing and able to sign an Informed Consent form to participate in the clinical study.
Who cannot join
- 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 exclusion Criteria:
- History of diabetes and/or a cardiovascular disease according to self-report
Show all 14Show fewer
- 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
- PAD group Inclusion Criteria:
- 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
- PAD group exclusion Criteria:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Medical subject headings
- Peripheral Arterial Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control NON-PAD | Measurement using the VOTIS PedCheck system | |
| PAD patients | Measurement using the VOTIS PedCheck system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 May 2022
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Votis Subdermal Imaging Technologies LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Responsible party
- Sponsor
- Investigators
- Hamutal Shahar, PhD, Study director, Votis Subdermal Imaging Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921461
- Sponsor's protocol ID
- PedCheck-V1-2.1
- Status last verified
- Jun 2023
- First submitted
- 10 May 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05921461
- Acronym / sponsor ID
- PedCheck-V1-2.1
- Conditions
- Peripheral Arterial Disease, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Votis Subdermal Imaging Technologies LTDIndustry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Study start
- 1 May 2022 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control NON-PAD | – | –Measurement using the VOTIS PedCheck system |
| PAD patients | – | –Measurement using the VOTIS PedCheck system |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be composed of 2 cohorts- * Control cohort - Up to 30 healthy non-PAD subjects * PAD cohort - Up to 30 PAD patients diagnosed with Peripheral Arterial Disease (PAD)
Key inclusion criteria (3 listed)
- Men and Women
- Age >40
- Subject must be willing and able to sign an Informed Consent form to participate in the clinical study.
Key exclusion criteria (14 listed)
- 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.
- Good health according to self-report
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severe adverse device effects or serious adverse events that are recorded using standard adverse event report forms
Time frame: 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).
Time frame: Through study completion, an average of 1 year.
HOVR score 0-100. 0-40 being no PAD, 40-100 being increasingly severe PAD.
2 secondary outcomes
Evaluation of usability based on collected data using standard convenience scoring questionnaires.
Time frame: Through study completion, an average of 1 year.
Evaluation of usability based on collected data using standard pain scoring questionnaires.
Time frame: Through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamutal Shahar, PhD study director
Votis Subdermal Imaging Technologies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Diabetes Mellitus, run by Votis Subdermal Imaging Technologies LTD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe adverse device effects or serious adverse events that are recorded using standard adverse event report forms (time frame: Through study completion, an average of 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.