NCT06436001

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

Comparing BlueDop Vascular Expert to Ankle-Brachial Index in the Identification of Peripheral Vascular Disease in All-comers and Diabetic Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 104 (actual)
• Sponsor: Dakota Vascular · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Peripheral Arterial Disease
• Diabetes Mellitus

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2024-05-30
• Last updated: 2024-06-03

Locations

1 site across 1 country: United States