An observational study in Peripheral Arterial Disease and Chronic Limb Ischemia, sponsored by Pedra Technology, PTE LTD. Completed at 1 site in United Kingdom. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-09-21.
Sponsored by Pedra Technology, PTE LTD · Observational
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Among 82 studies in Peripheral Arterial Disease with a site in United Kingdom — 20 open to participants now, 24 under way, 5 of them phase 3. Peripheral Arterial Disease · United Kingdom.
Among the 82 studies in Peripheral Arterial Disease with a site in United Kingdom, this one is the 26th largest by enrollment of the 31 observational ones that give a count, is one of 6 that started in 2018, is one of 31 observational ones, and was the 40th registered.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
Browse Peripheral Arterial Disease studies →20 of the 82 studies in Peripheral Arterial Disease with a site in United Kingdom are open now. Recruiting first, the newest first:
Cardiovascular and Interventional Radiological Society of Europe · Sites in United Kingdom
Ages 18+
Cardiovascular and Interventional Radiological Society of Europe · Sites in United Kingdom
Ages 18+
Regeneron Pharmaceuticals · Sites in United Kingdom, United States
Ages 18+
Hull University Teaching Hospitals NHS Trust · Sites in United Kingdom
Ages 18+ · Healthy volunteers
Eli Lilly and Company · Sites in United Kingdom, United States, Argentina and 15 more countries
Ages 18+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 192 Peripheral Arterial Disease studies recruiting now, 138 (72%) set no upper age limit and 9 (5%) stop at 75 or younger; 13 take children under 18; 19 take healthy volunteers.
This study: 40 Years to 90 Years · all sexes · no healthy volunteers.
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82 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 13 · Phase 4 2
First in 1997; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 68 is below the median of 188 across 398 observational studies indexed under Peripheral Arterial Disease.
Median enrollment 70 across the 51 interventional studies, 420 across the 31 observational. Of the 49 that completed or were terminated, 13 (27%) have results posted.
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26 of 82 have an industry lead sponsor. The 10 most frequent:
Pedra Technology, PTE LTD is the lead sponsor of 4 studies on the registry; none are open to participants now.
Pedra Technology, PTE LTD has 3 studies filed under Peripheral Arterial Disease — fewer than ten, so there is no comparison to draw.
1 of the studies in Peripheral Arterial Disease with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06827691Manchester Metropolitan UniversityHeat Therapy and Peripheral Artery Disease | 2027-11-20 |
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Among the 82 studies in Peripheral Arterial Disease with a site in United Kingdom, from their registry updates:
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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.
The 3 distinct subjects groups are divided as such:
General Inclusion Criteria:
Cohort Specific Inclusion Criteria:
Critical Limb Ischaemia Group Inclusion Criteria:
Peripheral Arterial Disease Group Inclusion Criteria:
PAD-Free Group Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Pedra Tissue Perfusion Monitor
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.
Device: Pedra Tissue Perfusion Monitor
Up to 20 subjects with no clinical diagnosis of peripheral vascular disease.
Device: Pedra Tissue Perfusion Monitor
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.
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).
Time frame: 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).
Time frame: 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).
Time frame: 36-hrs post-procedure/ discharge visit: 30-60 minutes after pad removal
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Dec 2019, 19 months.
Of 58 industry-sponsored observational studies under Peripheral Arterial Disease, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's 19 months is below that.
Counting every sponsor, half of 196 studies reached it within 36 months; a quarter within 22 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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