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

NCT06436001 | Completed

• 2 other identifiers: BlueDop_DakotaVascular studyCIRBI Link: CR00555039
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Arterial Disease; Diabetes Mellitus

Keywords

peripheral arterial disease; ankle brachial index; arterial duplex; Doppler waveform

Outcome Measures

Primary Outcomes (4)

• Sensitivity

  Comparing ABI and BVE findings to FLAD

  data collected from March 2023 to March 2024

• Specificity

  Comparing ABI and BVE findings to FLAD

  data collected from March 2023 to March 2024

• Accuracy

  Comparing ABI and BVE findings to FLAD

  data collected from March 2023 to March 2024

• Cohen's Kappa coefficient

  Comparing ABI and BVE findings to FLAD

  data collected from March 2023 to March 2024

Study Arms (2)

BlueDop Vascular Expert

BlueDop Vascular Expert assessment vs Full Leg Arterial Duplex

Ankle Brachial Index

ABI assessment verses Full Leg Arterial Duplex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dakota Vascular: lead

Study Sites (1)

Dakota Vascular

Sioux Falls, South Dakota, 57105, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 30, 2024
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

US (1)