Comparing BlueDop Vascular Expert to Ankle-Brachial Index in the Identification of Peripheral Vascular Disease

Dakota Vascular

Status: Completed

Conditions: Diabetes Mellitus; Peripheral Arterial Disease

Study type: Observational

Funder types: Other

Identifiers

NCT06436001

CIRBI Link: CR00555039 (Other Identifier)

BlueDop_DakotaVascular study

Details and patient eligibility

About

To compare the screening capabilities of the BlueDop Vascular Expert (BVE) and ankle brachial index (ABI) in peripheral arterial disease for all-comer patients and those with diagnosed diabetes mellitus.

Full description

This retrospective and prospective single-center study to compare the accuracy and screening capabilities of BVE and ABI with that of conventional Full Leg Arterial Duplex (FLAD) was performed at a private clinic in Sioux Falls, South Dakota, USA, with data collected from March 2023 to March 2024. Currently, BVE carries the European CE Mark but does not yet have FDA approval for use in the United States. This study was undertaken with local IRB approval.

Patients 18 years or older who presented to the center were consented to have BVE, ABI, and FLAD performed. BVE examination of lower extremity arteries were performed following the instruction for use (IFU). All examinations were performed by the same two registered vascular technologists. FLAD ultrasound was carried out with waveform interpretation interpreted by an outside cardiothoracic surgeon who specializes in treatment of arterial disease to determine the presence or absence of disease.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients 18 years or older who presented to the center were consented to have BVE, ABI, and FLAD performed.

Exclusion criteria

• Patients were excluded who had incomplete or inadequate data, if they were known to be currently pregnant, or if they had contraindications to Doppler ultrasound.

Trial design

104 participants in 2 patient groups

BlueDop Vascular Expert

Description:

BlueDop Vascular Expert assessment vs Full Leg Arterial Duplex

Ankle Brachial Index

Description:

ABI assessment verses Full Leg Arterial Duplex