None listed
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: NerveVue: NerveVue is a non-invasive, multi-sensor diagnostic device designed to assess peripheral arterial health by measuring hemodynamic and arterial pressure
Sponsors
Aarca Research India Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Age greater than or equal to 35 years. or Age 25 to 34 years with one or more of the following risk factors: - BMI greater than 25 kg/m - Elevated waist circumference: greater than 35 inches for women and greater than 40 inches for men - Habitually physically inactive (does not exercise regularly) - Has a first-degree relative with diabetes - Ethnicity with elevated risk for type 2 diabetes - Has delivered a baby weighing greater than 9 lb or was diagnosed with gestational diabetes - Hypertension (greater than or equal to 130/greater than or equal to 85 mmHg) or being treated for hypertension - HDL cholesterol level less than 35 mg/dL and/or a fasting triglyceride level greater than or equal to 250 mg/dL (or being treated for Dyslipidemia with medication) - Previously diagnosed with Polycystic Ovary Syndrome (PCOS) - Had impaired glucose tolerance or impaired fasting glucose on previous testing within the last three years - Conditions associated with insulin resistance, such as acanthosis nigricans - History of vascular disease including heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure, or peripheral arterial disease
Exclusion criteria
Exclusion criteria: Age under 25 years or - Received investigational treatments in the past 14 days. - Presence of psychosocial issues that interfere with the ability to follow study procedures. - conditions that causes secondary diabetes including cushing syndrome, acromegaly, hemochromatosis, Pancreatitis, or cystic fibrosis - Diagnosed with any type of diabetes, including type 1 or type 2 - Taking glucose-lowering medications with the exception of metformin. - Known to be pregnant - Receiving dialysis or having known renal compromise. - Scars, tattoos, rashes, or other disruptions/discolorations on the limbs or areas of sensor application that may interfere with proper usage of NerveVue. - Recent (within the past month) or current oral steroid therapy or chemotherapy, or chemotherapy within the past 12 months. - Receiving medications that fluoresce or known to have, or be at risk for, photosensitivity reactions (e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic Accuracy of NerveVue: The primary objective is to evaluate NerveVue s sensitivity and specificity in detecting early or subclinical Peripheral Arterial Disease (PAD). This includes comparing the device s measurement outputs (e.g., pulse-wave indices, perfusion metrics) against established diagnostic standards, such as the Ankle-Brachial Index (ABI) and Doppler Ultrasound.Timepoint: There is only one visit, i,e Baseline /screening /Enrolment visit | — |
Secondary
| Measure | Time frame |
|---|---|
| - Comparison with Standard Diagnostic Methods: A comparative analysis will be performed to assess the level of agreement between NerveVue results & existing PAD assessment techniques. Concordance, correlation coefficients, & potential advantages or limitations in various clinical environments will be documented. - Usability & Acceptability: The study will collect structured feedback from both participants & clinical personnel on factors such as ease of use, comfort, setup time, & overall user satisfaction. These insights will inform potential device refinements & practical considerations for routine clinical use. - Clinical Correlations: Data obtained through NerveVue will be examined in relation to other clinical or metabolic markers, such as patient-reported symptoms, comorbid conditions (e.g., diabetes), & broader cardiovascular risk profiles. - Feasibility of early detection- determine - Longitudinal MonitoringTimepoint: There is one visit, i,e Baseline /screening/Enrolment visit | — |
Countries
India
Contacts
Public ContactGayathri Choda
Aarca Research India Pvt, Ltd
Outcome results
None listed