Diabetic FootNCT04058626
TEsting for Arterial Disease in Diabetes (TrEAD) Study
An observational study of Diabetic Foot and Peripheral Arterial Disease, run by Imperial College Healthcare NHS Trust at 2 sites in United Kingdom.
Trial summary
This study will focus on determining; How accurate the test is in detecting poor circulation How it's accuracy compares to other commonly used tests, and Whether test results are linked to the chance of ulcer healing or amputation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Peripheral Arterial Disease, Diabetic Foot Ulcer
- What is being tested?
- Transcutaneous pressure of oxygen (TcPO2), Toe Brachial Pressure Index (TBPI) and Podiatry Ankle Duplex scan (PAD-scan)
- How many people
- 305 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 4 Mar 2019to 18 Oct 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients referred to the diabetic foot clinics at these sites will be asked to take part in the study.
Who may be able to join
- All diabetic patients presenting to the diabetic foot clinics will be eligible for the study.
Who cannot join
- Patients unable to provide informed consent will also be excluded.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
West Middlesex University Hospital
London, TW76AF
Imperial College NHS Healthcare Trust
London, W21NY
About this study
Official title: Comparative Diagnostic Accuracy Study of Bedside Tests Used to Detect Arterial Disease in Diabetes:
This study will focus on determining;
- How accurate the test is in detecting poor circulation
- How it's accuracy compares to other commonly used tests, and
- Whether test results are linked to the chance of ulcer healing or amputation. Across 2 hospitals, 305 diabetic patients will be scanned using the focused ultrasound test as well as other commonly used tests to detect poor circulation. Their results will be compared to a full version of the ultrasound test to identify the most accurate.
Read the detailed description
In the UK, over 7,000 amputations are performed each year because of diabetes. Most of these (80%) occur when a foot wound, also known as an ulcer, does not heal. The most important cause of this is poor circulation to the feet. Currently, there are no accurate tests that foot specialists can use to detect poor circulation when they see patients. Because of this, poor circulation can be missed and its treatment delayed.
A focused ultrasound test at the ankle, using a sensor and gel on the skin, can detect poor circulation. It is safe, painless and I have previously proven that it can be learned and performed quickly. It may help avoid amputations by detecting poor circulation so that it can be treated quickly.
- Conditions
- Diabetic Foot, Peripheral Arterial Disease, Diabetic Foot Ulcer, Peripheral Vascular Diseases, Peripheral Artery Disease, Critical Limb Ischemia
- Being tested
- Transcutaneous pressure of oxygen (TcPO2), Toe Brachial Pressure Index (TBPI), Podiatry Ankle Duplex scan (PAD-scan), Duplex Assist, Ankle Brachial Pressure Index (ABPI)
- Keywords
- Peripheral Vascular Diseases, Diabetic Foot, Critical Limb Ischemia, Diagnosis, Peripheral arterial disease, Diabetic foot ulcer, Duplex ultrasound, Ultrasound
- Medical subject headings
- Diabetic Foot, Peripheral Arterial Disease, Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous pressure of oxygen (TcPO2)Diagnostic test
Measurements will be taken from the dorsum of the foot using an automated machine equipped with Clark electrodes.
Toe Brachial Pressure Index (TBPI)Diagnostic test
TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.
Podiatry Ankle Duplex scan (PAD-scan)Diagnostic test
Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.
Duplex AssistDiagnostic test
Continuous Doppler device which gives visual display of arterial spectral waveform at the ankle.
Ankle Brachial Pressure Index (ABPI)Diagnostic test
A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the DPA and PTA.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy
Diagnostic accuracy of the PAD-scan and other bedside tests will be compared to the results of a full lower limb Duplex Ultrasound scan (reference test).
Measured: 1 hour; all tests will be performed on the same day of presentation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start4 Mar 2019
- Primary completion18 Oct 2019
- Study completion18 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaffer Usman, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058626
- Sponsor's protocol ID
- 17HH4091
- Status last verified
- Sep 2021
- First submitted
- 13 Aug 2019
- Last updated
- 2 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elghazaly H, Howard T, Sanjay S, Mohamed OG, Sounderajah V, Mehar Z, Davies AH, Jaffer U, Normahani P. Evaluating the prognostic performance of bedside tests used for peripheral arterial disease diagnosis in the prediction of diabetic foot ulcer healing. BMJ Open Diabetes Res Care. 2023 Mar;11(2):e003110. doi: 10.1136/bmjdrc-2022-003110.
PubMed 36918215Normahani P, Poushpas S, Alaa M, Bravis V, Aslam M, Jaffer U. Study protocol for a comparative diagnostic accuracy study of bedside tests used to detect arterial disease in diabetes: TEsting for Arterial disease in Diabetes (TrEAD) study. BMJ Open. 2020 Feb 5;10(2):e033753. doi: 10.1136/bmjopen-2019-033753.
PubMed 32029491
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Diagnostic Accuracy Study of Bedside Tests Used to Detect Arterial Disease in Diabetes:
- ClinicalTrials.gov ID
- NCT04058626
- Acronym / sponsor ID
- 17HH4091
- Conditions
- Diabetic Foot, Peripheral Arterial Disease, Diabetic Foot Ulcer, Peripheral Vascular Diseases, Peripheral Artery Disease, Critical Limb Ischemia
- Keywords
- Peripheral Vascular Diseases, Diabetic Foot, Critical Limb Ischemia, Diagnosis, Peripheral arterial disease, Diabetic foot ulcer, Duplex ultrasound, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Posted 2 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will focus on determining;
- How accurate the test is in detecting poor circulation
- How it's accuracy compares to other commonly used tests, and
- Whether test results are linked to the chance of ulcer healing or amputation. Across 2 hospitals, 305 diabetic patients will be scanned using the focused ultrasound test as well as other commonly used tests to detect poor circulation. Their results will be compared to a full version of the ultrasound test to identify the most accurate.
Detailed description
In the UK, over 7,000 amputations are performed each year because of diabetes. Most of these (80%) occur when a foot wound, also known as an ulcer, does not heal. The most important cause of this is poor circulation to the feet. Currently, there are no accurate tests that foot specialists can use to detect poor circulation when they see patients. Because of this, poor circulation can be missed and its treatment delayed.
A focused ultrasound test at the ankle, using a sensor and gel on the skin, can detect poor circulation. It is safe, painless and I have previously proven that it can be learned and performed quickly. It may help avoid amputations by detecting poor circulation so that it can be treated quickly.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients referred to the diabetic foot clinics at these sites will be asked to take part in the study.
Key inclusion criteria (1 listed)
- All diabetic patients presenting to the diabetic foot clinics will be eligible for the study.
Key exclusion criteria (1 listed)
- Patients unable to provide informed consent will also be excluded.
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 |
|---|---|---|
| Transcutaneous pressure of oxygen (TcPO2)Measurements will be taken from the dorsum of the foot using an automated machine equipped with Clark electrodes. | Diagnostic test | – |
| Toe Brachial Pressure Index (TBPI)TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger. | Diagnostic test | – |
| Podiatry Ankle Duplex scan (PAD-scan)Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle. | Diagnostic test | – |
| Duplex AssistContinuous Doppler device which gives visual display of arterial spectral waveform at the ankle. | Diagnostic test | – |
| Ankle Brachial Pressure Index (ABPI)A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the DPA and PTA. | Diagnostic test | – |
Primary outcome
Diagnostic Accuracy
Time frame: 1 hour; all tests will be performed on the same day of presentation.
Diagnostic accuracy of the PAD-scan and other bedside tests will be compared to the results of a full lower limb Duplex Ultrasound scan (reference test).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36918215Elghazaly H, Howard T, Sanjay S, Mohamed OG, Sounderajah V, Mehar Z, Davies AH, Jaffer U, Normahani P. Evaluating the prognostic performance of bedside tests used for peripheral arterial disease diagnosis in the prediction of diabetic foot ulcer healing. BMJ Open Diabetes Res Care. 2023 Mar;11(2):e003110. doi: 10.1136/bmjdrc-2022-003110.
- Derived from this study: PubMed 32029491Normahani P, Poushpas S, Alaa M, Bravis V, Aslam M, Jaffer U. Study protocol for a comparative diagnostic accuracy study of bedside tests used to detect arterial disease in diabetes: TEsting for Arterial disease in Diabetes (TrEAD) study. BMJ Open. 2020 Feb 5;10(2):e033753. doi: 10.1136/bmjopen-2019-033753.
- 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.
Jaffer Usman principal investigator
Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot and Peripheral Arterial Disease, run by Imperial College Healthcare NHS Trust at 2 sites 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 1 inclusion and 1 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 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 2 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Diagnostic Accuracy (time frame: 1 hour; all tests will be performed on the same day of presentation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04058626, which also lists 2 linked publications.
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 2 Sep 2021.