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NCT06436001 Clinical Trial

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
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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