Upstroke Time Measured by Photoplethysmography (TEMPO-DIAB)

Upstroke Time Measured by Photoplethysmography : Comparison With the Systolic Toe Pressure Index in a Population of Diabetic Arteriopaths

Peripherial arterial disease (PAD) and diabetes are major public health issues. In 2020, according to the latest epidemiological data, it is estimated that there will be more than one million patients with PAD and more than 3.5 million diabetic patients in France.

In the diabetic patient, screening for PAD is carried out by calculating the Toe-Brachial pressure index (TBi), a technique that remains time-consuming and technically demanding, which limits its use for clinical routine screening.

A new photoplethysmographic method (PPG) makes possible to determine the quality of peripheral perfusion thanks to the automatic computation of the upstroke time (TMS in ms).

This method appears to be a promising, inexpensive, faster and easier technical alternative to improve the dissemination of the vascular screening in diabetics.

To date, no prospective study has established a relationship between the measurement of upstroke time using the PPG method and TBi in a specific diabetic population.We will perform a two-centre prospective study (Nice University Hospital and Antibes Hospital) comparing the two techniques. The main objective of our study will compare the values of the upstroke time obtained by a PPG method and the TBi in a population of diabetic patients.

The secondary objectives will be to compare the TBi values to the ratio of the TMS measurements at the toe to the reference TMS measured at the hand and to determine the sensitivity-specificity of the TMS measured by PPG compared to the TBi in the detection of a significant PAD in diabetics.

Study Overview

• Status: Recruiting
• Conditions: Diabetes
• Intervention / Treatment: Device: POPMETRE® (Axelife , France)

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie BONNET; Phone Number: 04 92 03 85 48; Email: bonnet.s2@chu-nice.fr
• Study Contact Backup: Name: Gilles Di Lorenzo, Dr; Phone Number: 04 92 03 38 35; Email: di-lorenzo.g@chu-nice.fr

Study Locations

• France
  • Antibes, France
    • Recruiting
    • CH d'Antibes
    • Contact: Fabien Lareyre
  • Nice, France, 06000
    • Recruiting
    • CHU de Nice
    • Contact: Samantha AMRANI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient > 18 years, with no upper age limit
• Vascular assessment for PAD (screening or follow-up).
• Patient diagnosed with type 2 diabetes according to WHO diagnostic criteria (blood glucose > 1.26 g/l (7.0 mmol/l) after an 8-hour fast and checked twice ; or the presence of symptoms of diabetes (polyuria, polydipsia, weight loss) associated with a blood glucose level (on venous plasma) > 2 g/l (11.1 mmol/l); or a blood glucose level (on venous plasma) > 2 g/l (11.1 mmol/l) 2 hours after an oral glucose load of 75 g), under medical treatment or under dietary treatment alone.
• Patient having signed the informed consent form for the study.
• Patient with social security coverage.

Exclusion Criteria:

• Patient under 18 years of age
• Major amputations including transfemoral and transtibial amputations
• Ankle or toe lesions
• Any clinical condition of the patient not allowing measurements (acute ischaemia, pain, tremors...).
• Pregnant women, pregnant and breast feeding women, persons deprived of their freedom by a judicial or administrative decision, persons hospitalised without consent who are not covered by the provisions of Article L. 1121-8, and persons admitted to a health or social establishment for purposes other than research.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: diabetic patients with peripherial arterial disease; Patients will be included during a vascular medicine consultation for follow-up or screening for vascular pathology. Each subject will have their upstroke time measured by a new method of measurement using the device POPMETRE® (Axelife, France).	Device: POPMETRE® (Axelife , France); Measurement with 2 devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the values of upstroke time (TMS) obtained by a new method of measurement by PPG (photoplethysmographic) technique and IPSo	TMS measurement	1 hour

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Gilles Di Lorenzo, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Estimated): November 14, 2025
• Study Completion (Estimated): November 14, 2025

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 22-AOI-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No