Skip to content

Simplified and Easy Detection of Arterial Disease in Nursing Homes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03362710
Acronym
First-SEDAN
Enrollment
225
Registered
2017-12-05
Start date
2018-04-09
Completion date
2022-03-30
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artery Disease, Peripheral

Brief summary

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.

Detailed description

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: 1. Skin temperature on the back of the foot with infra-red thermometry 2. Toe saturometry 3. ABI with an automatic sphygmomanometry 4. Skin Recoloration time at the foot

Interventions

DIAGNOSTIC_TESTsimplified tools

1. Skin temperature on the back of the foot with infra-red thermometry 2. Toe saturometry 3. ABI with an automatic sphygmomanometry 4. Skin Recoloration time at the foot

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Performance of non-invasive measurements1 hourPerformance 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026