Recruiting

NCT Number: NCT05795582

Upstroke Time Measured by Photoplethysmography

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH d'Antibes, Antibes, France

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

POPMETRE® (Axelife , France)

Device

Measurement with 2 devices

Primary outcomes

Comparison of the values of upstroke time (TMS) obtained by a new method of measurement by PPG (photoplethysmographic) technique and IPSo

Time frame: 1 hour

TMS measurement

Study contacts

Contact information is provided by the study sponsor or research team.

Gilles Di Lorenzo, Dr

CONTACT

[email protected]

04 92 03 38 35

Sophie BONNET

CONTACT

[email protected]

04 92 03 85 48

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: TEMPO-DIAB

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Apr 3, 2023
Registry last updated: Jun 17, 2026

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.

Recruiting