CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 305 enrolled
Drug / intervention
Transcutaneous pressure of oxygen (TcPO2) +4 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04058626
NCT04058626N/ACompleted

Comparative Diagnostic Accuracy Study of Bedside Tests Used to Detect Arterial Disease in Diabetes:

Imperial College Healthcare NHS Trust·observational·Posted Aug 15, 2019·Updated Sep 2, 2021

In Brief

An observational study evaluating Transcutaneous pressure of oxygen (TcPO2), Toe Brachial Pressure Index (TBPI), and 3 other interventions for Diabetic Foot and 6 related conditions. Completed, enrolled 305 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 15, 2019
Enrollment StartMar 4, 2019
Primary CompletionOct 18, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.9 years ago

Interventions

Transcutaneous pressure of oxygen (TcPO2)other

Measurements will be taken from the dorsum of the foot using an automated machine equipped with Clark electrodes.

Toe Brachial Pressure Index (TBPI)other

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)other

Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.

Duplex Assistother

Continuous Doppler device which gives visual display of arterial spectral waveform at the ankle.

Ankle Brachial Pressure Index (ABPI)other

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.