Peripheral Arterial DiseaseIROADNCT03294902
Improving Radiological Outcomes in Arterial Disease - A Pilot Evaluation of the Pedra Tissue Perfusion Monitoring System
An observational study of Peripheral Arterial Disease and Chronic Limb Ischemia, run by Pedra Technology, PTE LTD at 1 site in United Kingdom.
Trial summary
The Pedra Technologies' PedraTM device is a non-invasive, diagnostic device intended to measure foot perfusion by assessing blood flow. The PedraTM device comprises a compact instrument console connected to a sensor that is pasted onto the patient's foot during perfusion assessment. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Peripheral Arterial Disease, Chronic Limb Ischemia
- What is being tested?
- Pedra Tissue Perfusion Monitor
- Type of treatment
- Medical device
- How many people
- 68 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 May 2018to 30 Jun 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The 3 distinct subjects groups are divided as such: * Critical Limb Ischaemia (CLI) Group with tibial arterial disease: Up to 20, but at least 8 subjects with a Rutherford grade 4 or 5 critically ischemic foot, where the primary intention is to treat at least one occluded tibial vessel or 2 severely stenosed tibial vessels. The treatment of SFA stenoses of less than 70%, as confirmed by duplex or CT, is acceptable in parallel in this group. * Peripheral Artery Disease (PAD) Group with SFA disease: Up to 20, but at least 8 subjects with a clinical diagnosis of claudication and duplex or CT-confirmed SFA stenoses greater than 70%, with no intention of primarily treating any tibial disease at this encounter. * PAD-free Group (Healthy Volunteer Group): Up to 20 subjects with no clinical diagnosis of peripheral vascular disease.
Who may be able to join
None listed.
Who cannot join
- Infusion of vasoactive medications within the past 24 hours
- The presence of a known chronic history of anaemia (i.e. Hb <8g/dL)
- Congestive heart failure defined by NYHA Classification 3 or 4
- The absence of intact skin at suitable measurement sites on the foot.
- The presence of invasive soft tissue infection in the toes spreading into the forefoot.
- The presence of physical impediment to the method of measurements being completed (i.e. absent first two toes, extensive ulceration, excessive oedema, pressure dressings or heavy bandaging, etc.)
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- The presence of a non-salvageable foot or a Rutherford 6 wound.
- The presence of other conditions, which in the opinion of the Investigator, may compromise the subject safety or comfort.
- The presence of other conditions, which in the opinion of the Investigator, may compromise the accuracy of the data obtained.
- The patient is a vulnerable or protected adult, or is unable to provide consent.
- The patient is unable to comply with the measurement protocol.
- Pregnant subjects
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Addenbrooke's Hospital, Department of Vascular Surgery
Cambridge, CB2 0QQ
About this study
The Pedra Technologies' PedraTM device is a non-invasive, diagnostic device intended to measure foot perfusion by assessing blood flow. The PedraTM device comprises a compact instrument console connected to a sensor that is pasted onto the patient's foot during perfusion assessment. Through skin contact, the device is able to monitor tissue perfusion at depths of up to 7.5mm. The monitor console contains opto-electronic instrumentation including coherent infrared light sources, photo detectors, and display/control electronics. The sensor comprises passive fiber-optic conduits, which transfer infrared light from the console to the patient, and relays scattered light from the patient back to the console. The intensity of light emitted from the sensor is less than 3 mW, well within the safety envelope of Class I laser systems and comparable (or lower than) other commercially available devices such as laser Doppler systems. The sole point of contact with the patient is a layer of medical grade adhesive tape, which is used to paste the flat sensor onto intact skin.
- Conditions
- Peripheral Arterial Disease, Chronic Limb Ischemia
- Being tested
- Pedra Tissue Perfusion Monitor
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedra Tissue Perfusion MonitorDevice
This study is a prospective single-centre, device observational study designed to enroll up to 60 evaluable subjects at 1 investigational site in the United Kingdom. Eligible subjects, who meet the requirements for one of the 3 distinct subject groups: (1) Critical Limb Ischaemia group, (2) Peripheral artery disease with superficial femoral arterial (SFA) or popliteal artery disease and (3) PAD-free group. Subjects who meet study eligibility criteria will be enrolled consecutively until the total number of subjects is enrolled per each group as outlined in the protocol. All subjects at the investigational site will be enrolled in the presence of a member of the Sponsor or selected designee in order to assist with the device operation and to verify that all protocol assessments are completed appropriately at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Critical Limb Ischaemia (CLI) Group with tibial arterial dis | Up to 20, but at least 8 subjects with a Rutherford grade 4 or 5 critically ischemic foot, where the primary intention is to treat at least one occluded tibial vessel or 2 severely stenosed tibial vessels. The treatment of SFA stenoses of less than 70%, as confirmed by duplex or CT, is acceptable in parallel in this group. Receives: Device: Pedra Tissue Perfusion Monitor | |
| Peripheral Artery Disease (PAD) Group with SFA disease | Up to 20, but at least 8 subjects with a clinical diagnosis of claudication and duplex or CT-confirmed SFA stenoses greater than 70%, with no intention of primarily treating any tibial disease at this encounter. Receives: Device: Pedra Tissue Perfusion Monitor | |
| PAD-free group (Healthy Volunteer Group) | Up to 20 subjects with no clinical diagnosis of peripheral vascular disease. Receives: Device: Pedra Tissue Perfusion Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline safety endpoint: The absence of immediately observable skin reaction (rash; local oedema, blistering of the skin) in ≥ 90% of subjects after removal of the Pedra sensors.
This observation assessment is completed by the physician post removal of the adhesive pads. It is either a "yes" or a "no" in observing if there is a skin reaction to the adhesive pads when they are removed from the skin and also documentation of what type of reaction (rash; local oedema, blistering of the skin).
Measured: Baseline visit: 30-60 minutes after pad removal
During procedure safety endpoint: The absence of immediately observable skin reaction (rash; local oedema, blistering of the skin) in ≥ 90% of subjects after removal of the Pedra sensors.
This observation assessment is completed by the physician post removal of the adhesive pads. It is either a "yes" or a "no" in observing if there is a skin reaction to the adhesive pads when they are removed from the skin and also documentation of what type of reaction (rash; local oedema, blistering of the skin).
Measured: During procedure visit: 30-60 minutes after pad removal
36-hrs post-procedure/ discharge visit safety endpoint: The absence of immediately observable skin reaction (rash; local oedema, blistering of the skin) in ≥ 90% of subjects after removal of the Pedra sensors.
This observation assessment is completed by the physician post removal of the adhesive pads. It is either a "yes" or a "no" in observing if there is a skin reaction to the adhesive pads when they are removed from the skin and also documentation of what type of reaction (rash; local oedema, blistering of the skin).
Measured: 36-hrs post-procedure/ discharge visit: 30-60 minutes after pad removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start30 May 2018
- Primary completion31 Dec 2019
- Study completion30 Jun 2020
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pedra Technology, PTE LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294902
- Sponsor's protocol ID
- CIP-01
- Acronym
- IROAD
- Status last verified
- Sep 2020
- First submitted
- 25 Aug 2017
- Last updated
- 21 Sep 2020
- 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 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Radiological Outcomes in Arterial Disease - A Pilot Evaluation of the Pedra Tissue Perfusion Monitoring System
- ClinicalTrials.gov ID
- NCT03294902
- Acronym / sponsor ID
- IROAD / CIP-01
- Conditions
- Peripheral Arterial Disease, Chronic Limb Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Pedra Technology, PTE LTDIndustry (pharma, biotech, devices)
- Study start
- 30 May 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 27 Sep 2017 (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.
The Pedra Technologies' PedraTM device is a non-invasive, diagnostic device intended to measure foot perfusion by assessing blood flow. The PedraTM device comprises a compact instrument console connected to a sensor that is pasted onto the patient's foot during perfusion assessment. Through skin contact, the device is able to monitor tissue perfusion at depths of up to 7.5mm. The monitor console contains opto-electronic instrumentation including coherent infrared light sources, photo detectors, and display/control electronics. The sensor comprises passive fiber-optic conduits, which transfer infrared light from the console to the patient, and relays scattered light from the patient back to the console. The intensity of light emitted from the sensor is less than 3 mW, well within the safety envelope of Class I laser systems and comparable (or lower than) other commercially available devices such as laser Doppler systems. The sole point of contact with the patient is a layer of medical grade adhesive tape, which is used to paste the flat sensor onto intact skin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Critical Limb Ischaemia (CLI) Group with tibial arterial dis | – | Device: Pedra Tissue Perfusion MonitorUp to 20, but at least 8 subjects with a Rutherford grade 4 or 5 critically ischemic foot, where the primary intention is to treat at least one occluded tibial vessel or 2 severely stenosed tibial vessels. The treatment of SFA stenoses of less than 70%, as confirmed by duplex or CT, is acceptable in parallel in this group. |
| Peripheral Artery Disease (PAD) Group with SFA disease | – | Device: Pedra Tissue Perfusion MonitorUp to 20, but at least 8 subjects with a clinical diagnosis of claudication and duplex or CT-confirmed SFA stenoses greater than 70%, with no intention of primarily treating any tibial disease at this encounter. |
| PAD-free group (Healthy Volunteer Group) | – | Device: Pedra Tissue Perfusion MonitorUp to 20 subjects with no clinical diagnosis of peripheral vascular disease. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The 3 distinct subjects groups are divided as such: * Critical Limb Ischaemia (CLI) Group with tibial arterial disease: Up to 20, but at least 8 subjects with a Rutherford grade 4 or 5 critically ischemic foot, where the primary intention is to treat at least one occluded tibial vessel or 2 severely stenosed tibial vessels. The treatment of SFA stenoses of less than 70%, as confirmed by duplex or CT, is acceptable in parallel in this group. * Peripheral Artery Disease (PAD) Group with SFA disease: Up to 20, but at least 8 subjects with a clinical diagnosis of claudication and duplex or CT-confirmed SFA stenoses greater than 70%, with no intention of primarily treating any tibial disease at this encounter. * PAD-free Group (Healthy Volunteer Group): Up to 20 subjects with no clinical diagnosis of peripheral vascular disease.
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Infusion of vasoactive medications within the past 24 hours
- The presence of a known chronic history of anaemia (i.e. Hb <8g/dL)
- Congestive heart failure defined by NYHA Classification 3 or 4
- The absence of intact skin at suitable measurement sites on the foot.
- The presence of invasive soft tissue infection in the toes spreading into the forefoot.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pedra Tissue Perfusion MonitorThis study is a prospective single-centre, device observational study designed to enroll up to 60 evaluable subjects at 1 investigational site in the United Kingdom. Eligible subjects, who meet the requirements for one of the 3 distinct subject groups: (1) Critical Limb Ischaemia group, (2) Peripheral artery disease with superficial femoral arterial (SFA) or popliteal artery disease and (3) PAD-free group. Subjects who meet study eligibility criteria will be enrolled consecutively until the total number of subjects is enrolled per each group as outlined in the protocol. All subjects at the investigational site will be enrolled in the presence of a member of the Sponsor or selected designee in order to assist with the device operation and to verify that all protocol assessments are completed appropriately at baseline. | Device | Critical Limb Ischaemia (CLI) Group with tibial arterial dis, PAD-free group (Healthy Volunteer Group), Peripheral Artery Disease (PAD) Group with SFA disease |
Primary outcome
Baseline safety endpoint: The absence of immediately observable skin reaction (rash; local oedema, blistering of the skin) in ≥ 90% of subjects after removal of the Pedra sensors.
Time frame: Baseline visit: 30-60 minutes after pad removal
This observation assessment is completed by the physician post removal of the adhesive pads. It is either a "yes" or a "no" in observing if there is a skin reaction to the adhesive pads when they are removed from the skin and also documentation of what type of reaction (rash; local oedema, blistering of the skin).
During procedure safety endpoint: The absence of immediately observable skin reaction (rash; local oedema, blistering of the skin) in ≥ 90% of subjects after removal of the Pedra sensors.
Time frame: During procedure visit: 30-60 minutes after pad removal
This observation assessment is completed by the physician post removal of the adhesive pads. It is either a "yes" or a "no" in observing if there is a skin reaction to the adhesive pads when they are removed from the skin and also documentation of what type of reaction (rash; local oedema, blistering of the skin).
36-hrs post-procedure/ discharge visit safety endpoint: The absence of immediately observable skin reaction (rash; local oedema, blistering of the skin) in ≥ 90% of subjects after removal of the Pedra sensors.
Time frame: 36-hrs post-procedure/ discharge visit: 30-60 minutes after pad removal
This observation assessment is completed by the physician post removal of the adhesive pads. It is either a "yes" or a "no" in observing if there is a skin reaction to the adhesive pads when they are removed from the skin and also documentation of what type of reaction (rash; local oedema, blistering of the skin).
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 21 Sep 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Limb Ischemia, run by Pedra Technology, PTE LTD at 1 site in United Kingdom.
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 0 inclusion and 12 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 21 Sep 2020. 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 United Kingdom. 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?
Baseline safety endpoint: The absence of immediately observable skin reaction (rash; local oedema, blistering of the skin) in ≥ 90% of subjects after removal of the Pedra sensors. (time frame: Baseline visit: 30-60 minutes after pad removal). The study lists 3 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 21 Sep 2020.