Trial Outcomes & Findings for TEsting for Arterial Disease in Diabetes (TrEAD) Study (NCT NCT04058626)
NCT ID: NCT04058626
Last Updated: 2021-09-02
Results Overview
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).
COMPLETED
305 participants
1 hour; all tests will be performed on the same day of presentation.
2021-09-02
Participant Flow
Participant milestones
| Measure |
Study Participants
Participants with diabetes were consecutively enrolled into the study across 2 centers.
|
|---|---|
|
Overall Study
STARTED
|
305
|
|
Overall Study
COMPLETED
|
305
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Participants
n=305 Participants
Participants with diabetes were consecutively enrolled into the study across 2 centers.
|
|---|---|
|
Age, Continuous
|
72 years
n=305 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=305 Participants
|
|
Sex: Female, Male
Male
|
206 Participants
n=305 Participants
|
|
Active ulceration
|
123 Participants
n=305 Participants
|
|
Neuropathy
|
203 Participants
n=305 Participants
|
PRIMARY outcome
Timeframe: 1 hour; all tests will be performed on the same day of presentation.Population: Missing data were observed in 7 (2.3%) patients for ABPI, 71 (23.3%) patients for TBPI and 16 (5.2%) patients for TcPO2.
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).
Outcome measures
| Measure |
Study Participants
n=305 Participants
Participants with diabetes were consecutively enrolled into the study across 2 centers.
|
|---|---|
|
Diagnostic Accuracy
PAD-scan sensitivity
|
95 Percent
Interval 90.0 to 97.0
|
|
Diagnostic Accuracy
PAD-scan specificity
|
77 Percent
Interval 67.0 to 84.0
|
|
Diagnostic Accuracy
TBPI sensitivity
|
60 Percent
Interval 51.0 to 68.0
|
|
Diagnostic Accuracy
TBPI specificity
|
86 Percent
Interval 77.0 to 92.0
|
|
Diagnostic Accuracy
Pulse sensitivity
|
43 Percent
Interval 36.0 to 50.0
|
|
Diagnostic Accuracy
Pulse specificity
|
81 Percent
Interval 72.0 to 88.0
|
|
Diagnostic Accuracy
Doppler (audible) sensitivity
|
74 Percent
Interval 67.0 to 80.0
|
|
Diagnostic Accuracy
Doppler (audible) specificity
|
76 Percent
Interval 66.0 to 84.0
|
|
Diagnostic Accuracy
Doppler (visual) sensitivity
|
83 Percent
Interval 77.0 to 88.0
|
|
Diagnostic Accuracy
Doppler (visual) specificity
|
75 Percent
Interval 65.0 to 83.0
|
|
Diagnostic Accuracy
ABPI sensitivity
|
60 Percent
Interval 53.0 to 67.0
|
|
Diagnostic Accuracy
ABPI specificity
|
75 Percent
Interval 66.0 to 83.0
|
|
Diagnostic Accuracy
TcPO2 sensitivity
|
31 Percent
Interval 24.0 to 38.0
|
|
Diagnostic Accuracy
TcPO2 specificity
|
79 Percent
Interval 69.0 to 86.0
|
Adverse Events
Study Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mr Pasha Normahani
Imperial College London/ Imperial College Healthcare NHS Trust
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place