Simplified and Easy Detection of Arterial Disease in Nursing Homes

NCT03362710 | Completed DMC

• 1 other identifier: 2017-A02635-48
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Artery Disease, Peripheral

Outcome Measures

Primary Outcomes (1)

• Performance of non-invasive measurements

  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

  1 hour

Study Arms (1)

PAD patients

EXPERIMENTAL

Patients referred for an arterial doppler assessment of lower limbs will be included. Intervention is a series of examination, followed by the measurement of the ABI and an arterial echo-doppler of the lower limbs +/- transcutaneous oxygen pressure measurements in case of suspected critical limb ischemia. A technician will perform the evaluation with simplified tools blinded to the results of vascular specialised investigations

Diagnostic Test: simplified tools

Interventions

simplified tools DIAGNOSTIC_TEST

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

PAD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients protected by law
• Patients unable to understand the objectives or instructions of the study

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, 49933, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Samir HENNI, MD,PhD

  UH Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 5, 2017
• Study Start: April 9, 2018
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: March 31, 2022

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)