Measuring blood flow in diabetic patients using a new method
Upstroke Time Measured by Photoplethysmography : Comparison With the Systolic Toe Pressure Index in a Population of Diabetic Arteriopaths
This study is testing a new, quicker way to measure blood flow in diabetic patients to see if it can help spot peripheral arterial disease more easily than the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 2 sites (Antibes and 1 other locations) |
| Trial ID | NCT05795582 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with type 2 diabetes who require vascular assessment for PAD.
Not a fit: Patients under 18 years of age, those with major amputations, or any clinical conditions preventing measurements will not benefit from this study.
Why it matters
Potential benefit: If successful, this method could streamline the screening process for PAD in diabetic patients, leading to earlier diagnosis and treatment.
How similar studies have performed: While this approach is innovative, no prior prospective studies have established a relationship between the PPG method and TBi specifically in diabetic populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Antibes and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.