Upstroke Time Measured by Photoplethysmography

Diabetes Clinical Trial

— TEMPO-DIAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795582
• Other study ID #: 22-AOI-07
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2023
• Est. completion date: November 14, 2025

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Gilles Di Lorenzo, Dr
• Phone: 04 92 03 38 35
• Email: di-lorenzo.g[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 14, 2025
• Est. primary completion date: November 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• POPMETRE® (Axelife , France)
Measurement with 2 devices

Locations

Country	Name	City	State
France	CH d'Antibes	Antibes
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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