Upstroke Time Measured by Photoplethysmography

NCT05795582 | Unknown

• 1 other identifier: 22-AOI-07
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

diabetic patients with peripherial arterial disease

EXPERIMENTAL

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)

Interventions

POPMETRE® (Axelife , France) DEVICE

Measurement with 2 devices

diabetic patients with peripherial arterial disease

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

CH d'Antibes

Antibes, France

RECRUITING

CHU de Nice

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Gilles Di Lorenzo

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilles Di Lorenzo, Dr

CONTACT

04 92 03 38 35; di-lorenzo.g@chu-nice.fr

Sophie BONNET

CONTACT

04 92 03 85 48; bonnet.s2@chu-nice.fr

Study Design

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

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: June 14, 2023
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)