Simplified and Easy Detection of Arterial Disease in Nursing Homes

Peripheral artery disease (PAD) affects mainly elderly patients. The ankle brachial index (ABI) and ultrasound imaging are the standard diagnostic tools in PAD diagnostic and severity estimation. Measurements are generally performed by a vascular physician. However, access to medical specialist is becoming increasingly difficult with long waiting times while the aging of the population increases, while most of these patients are seen by the general practitioner.

To date, there is a lot of data in the literature on the value of using various ambulatory devices in the diagnosis and severity estimation of PAD but studied one by one.

The investigators propose to compare the measurements made by a series of simple non-invasive ambulatory tools with the measurements performed by the vascular specialist. The investigators wish to demonstrate that a series of simple and economical tools, available to paramedical health professionals can diagnose PAD and evaluate ts severity the reducing the direct and indirect associated costs.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Artery Disease, Peripheral Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers

Angers, 49933, France

About this study

Patients referred for an arterial vascular investigations of the lower limbs will be included.

After signing the consent, all included patients will be assessed by the examination series, among which ABI measurement and an arterial Doppler ultrasound of the lower limbs +/- transcutaneous oxygen pressure recording in case of suspected critical limb ischemia. Following the visit patients will be classified as have or not PAD and in case of PAD classified for the severity of PAD on the basis of the investigation results.

Blinded to the results of the vascular laboratory test, a technician will:

Measure ABI with an automatic sphygmomanometer.

Examination series:

Skin temperature on the back of the foot with infra-red thermometry
Toe saturometry
ABI with an automatic sphygmomanometry
Skin Recoloration time at the foot

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients referred for arterial assessment of the lower limbs as part of a screening or follow-up of PAD
Patients without contraindications for all non-invasive measures
Age superior to 18 years
Affiliated patients of a social security scheme
Patients who have signed informed consent.

Exclusion criteria

Patients protected by law
Patients unable to understand the objectives or instructions of the study
Patients in an exclusion period relative to another biomedical study.

Treatment and study plan

simplified tools

Diagnostic Test

Skin temperature on the back of the foot with infra-red thermometry
Toe saturometry
ABI with an automatic sphygmomanometry
Skin Recoloration time at the foot

Primary outcomes

Performance of non-invasive measurements

Time frame: 1 hour

Performance of the score will be studied with the receiver operating characteristic (ROC) approach and multivariate analysis using echo-doppler and transcutaneous oxymetry results as references for PAD severity classification standard

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

Evaluation du Risque Vasculaire Par Mesures Non Invasives en Soins Primaires.

Acronym: First-SEDAN

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Dec 5, 2017
Registry last updated: Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed