N/A
N=305
TEsting for Arterial Disease in Diabetes (TrEAD) Study
Diabetic Foot · Peripheral Arterial Disease · Diabetic Foot Ulcer · Peripheral Vascular Diseases · Peripheral Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT04058626 ↗Enrolled (actual)
305
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Diagnostic Accuracy — 95; 77; 60; 86 Percent
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 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) (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College Healthcare NHS Trust
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Accuracy |
95; 77; 60; 86; 43; 81 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04058626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.