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TEsting for Arterial Disease in Diabetes (TrEAD) Study

NCT04058626 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 305

Last updated 2021-09-02

Study results available
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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.

Conditions

  • Diabetic Foot
  • Peripheral Arterial Disease
  • Diabetic Foot Ulcer
  • Peripheral Vascular Diseases
  • Peripheral Artery Disease
  • Critical Limb Ischemia
  • Critical Lower Limb Ischemia

Interventions

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.

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    lead OTHER

Principal Investigators

  • Jaffer Usman · Imperial College London

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-04
Primary Completion
2019-10-18
Completion
2019-10-18

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04058626 on ClinicalTrials.gov