TEsting for Arterial Disease in Diabetes (TrEAD) Study

NCT04058626 | Completed Results

• 1 other identifier: 17HH4091
• Study Type: observational
• Target: 305
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Peripheral Vascular Diseases; Diabetic Foot; Critical Limb Ischemia; Diagnosis; Peripheral arterial disease; Diabetic foot ulcer; Duplex ultrasound; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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).

  1 hour; all tests will be performed on the same day of presentation.

Interventions

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 Assist DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients unable to provide informed consent will also be excluded.

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (2)

West Middlesex University Hospital

London, TW76AF, United Kingdom

Location

Imperial College NHS Healthcare Trust

London, W21NY, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 36918215 DERIVED

• Normahani 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.

  PMID: 32029491 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Peripheral Arterial Disease; Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia; Disease

Interventions

Ankle Brachial Index

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Mr Pasha Normahani
• Organization: Imperial College London/ Imperial College Healthcare NHS Trust

p.normahani@imperial.ac.uk

020 3312 6666

Study Officials

• Jaffer Usman

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 15, 2019
• Study Start: March 4, 2019
• Primary Completion: October 18, 2019
• Study Completion: October 18, 2019
• Last Updated: September 2, 2021
• Results First Posted: September 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)