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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06436001
• Other study ID #: BlueDop_DakotaVascular study
• Secondary ID: CIRBI Link: CR00
• Status: Completed
• Start date: March 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: May 2024
• Source: Dakota Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Locations

Country	Name	City	State
United States	Dakota Vascular	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Dakota Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Comparing ABI and BVE findings to FLAD	data collected from March 2023 to March 2024
Primary	Specificity	Comparing ABI and BVE findings to FLAD	data collected from March 2023 to March 2024
Primary	Accuracy	Comparing ABI and BVE findings to FLAD	data collected from March 2023 to March 2024
Primary	Cohen's Kappa coefficient	Comparing ABI and BVE findings to FLAD	data collected from March 2023 to March 2024