TEMPO-DIAB: Upstroke Time Measured by Photoplethysmography

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05795582

Collaborator

(none)

120

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Device: POPMETRE® (Axelife , France)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2025

Anticipated Study Completion Date :

Nov 30, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Comparison of the values of upstroke time (TMS) obtained by a new method of measurement by PPG (photoplethysmographic) technique and IPSo [1 hour]
TMS measurement

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CH d'Antibes	Antibes		France
2	CHU de Nice	Nice		France	06000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

Principal Investigator: Samantha AMRANI, Centre Hospitalier Universitaire de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT05795582

Other Study ID Numbers:

22-AOI-07

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 3, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 3, 2023