## Protocol Section
### Identification Module
**NCT ID:** NCT06436001

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

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

#### Organization Study ID Info
**ID:** BlueDop_DakotaVascular study
#### Organization
**Class:** OTHER
**Full Name:** Dakota Vascular
#### Secondary ID Infos
**Domain:** Advarra IRB
**ID:** CIRBI Link: CR00555039
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-03-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-03-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Dakota Vascular

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Peripheral Arterial Disease

- Diabetes Mellitus

**Keywords:**

- peripheral arterial disease

- ankle brachial index

- arterial duplex

- Doppler waveform

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 104

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** BlueDop Vascular Expert assessment vs Full Leg Arterial Duplex

**Label:** BlueDop Vascular Expert

#### Arm Group 2

**Description:** ABI assessment verses Full Leg Arterial Duplex

**Label:** Ankle Brachial Index

### Outcomes Module

#### Primary Outcomes

**Description:** Comparing ABI and BVE findings to FLAD

**Measure:** Sensitivity

**Time Frame:** data collected from March 2023 to March 2024

**Description:** Comparing ABI and BVE findings to FLAD

**Measure:** Specificity

**Time Frame:** data collected from March 2023 to March 2024

**Description:** Comparing ABI and BVE findings to FLAD

**Measure:** Accuracy

**Time Frame:** data collected from March 2023 to March 2024

**Description:** Comparing ABI and BVE findings to FLAD

**Measure:** Cohen's Kappa coefficient

**Time Frame:** data collected from March 2023 to March 2024

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Sioux Falls

**Country:** United States

**Facility:** Dakota Vascular

**State:** South Dakota

**Zip:** 57105

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000050197

- Term: Atherosclerosis

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: HIGH

- As Found: Vascular Disease

- ID: M29213

- Name: Peripheral Arterial Disease

- Relevance: HIGH

- As Found: Peripheral Arterial Disease

- ID: M18894

- Name: Peripheral Vascular Diseases

- Relevance: HIGH

- As Found: Peripheral Vascular Disease

- ID: M26188

- Name: Atherosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000058729

- Term: Peripheral Arterial Disease

- ID: D000016491

- Term: Peripheral Vascular Diseases

- ID: D000014652

- Term: Vascular Diseases

### Misc Info Module

- Version Holder: 2024-05-31
