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TEsting for Arterial Disease in Diabetes (TrEAD) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04058626
Recruitment Status : Completed
First Posted : August 15, 2019
Results First Posted : September 2, 2021
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Diabetic Foot Peripheral Arterial Disease Diabetic Foot Ulcer Peripheral Vascular Diseases Peripheral Artery Disease Critical Limb Ischemia Critical Lower Limb Ischemia Diagnostic Test: Transcutaneous pressure of oxygen (TcPO2) Diagnostic Test: Toe Brachial Pressure Index (TBPI) Diagnostic Test: Podiatry Ankle Duplex scan (PAD-scan) Diagnostic Test: Duplex Assist Diagnostic Test: Ankle Brachial Pressure Index (ABPI)

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
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Study Type : Observational
Actual Enrollment : 305 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Comparative Diagnostic Accuracy Study of Bedside Tests Used to Detect Arterial Disease in Diabetes:
Actual Study Start Date : March 4, 2019
Actual Primary Completion Date : October 18, 2019
Actual Study Completion Date : October 18, 2019
Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: 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 Assist
    Continuous 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.

Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients referred to the diabetic foot clinics at these sites will be asked to take part in the study.
Criteria

Inclusion Criteria:

  • All diabetic patients presenting to the diabetic foot clinics will be eligible for the study.

Exclusion Criteria:

  • Patients unable to provide informed consent will also be excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058626


Locations
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United Kingdom
West Middlesex University Hospital
London, United Kingdom, TW76AF
Imperial College NHS Healthcare Trust
London, United Kingdom, W21NY
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
Investigators
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Principal Investigator: Jaffer Usman Imperial College London
  Study Documents (Full-Text)

Documents provided by Imperial College Healthcare NHS Trust:
Study Protocol and Statistical Analysis Plan  [PDF] February 1, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT04058626    
Other Study ID Numbers: 17HH4091
First Posted: August 15, 2019    Key Record Dates
Results First Posted: September 2, 2021
Last Update Posted: September 2, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College Healthcare NHS Trust:
Peripheral Vascular Diseases
Diabetic Foot
Critical Limb Ischemia
Diagnosis
 Peripheral arterial disease
Diabetic foot ulcer
Duplex ultrasound
Ultrasound
Additional relevant MeSH terms:
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Diabetic Foot
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Foot Ulcer
Ischemia
Pathologic Processes
Diabetic Angiopathies
Cardiovascular Diseases
Leg Ulcer
 Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases