Measuring blood flow in diabetic patients using a new method

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate a novel photoplethysmographic method for measuring upstroke time in diabetic patients to screen for peripheral arterial disease (PAD). The traditional Toe-Brachial pressure index (TBi) method is time-consuming and technically demanding, which limits its routine clinical use. The new approach promises to be faster, easier, and more cost-effective, potentially improving vascular screening for diabetes patients. The study will compare the upstroke time measurements obtained through this method with the TBi in a specific diabetic population.

Why it matters

Who can join: the full rules

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.

Where it's running

• CH d'Antibes
  Antibes, France Recruiting
• CHU de Nice
  Nice, France Recruiting

Study contacts

• Principal investigator: Gilles Di Lorenzo — Centre Hospitalier Universitaire de Nice
• Study coordinator: Gilles Di Lorenzo, Dr
• Email: di-lorenzo.g@chu-nice.fr
• Phone: 04 92 03 38 35

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.