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Assessment of the Ankle Systolic Pressure Index in Patients Over 70 Years of Age With Jaundice Ulcer

Assessment of the Ankle Systolic Pressure Index in Patients Over 70 Years of Age With Jaundice Ulcer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04794192
Acronym
IPScheville
Enrollment
53
Registered
2021-03-11
Start date
2019-11-25
Completion date
2023-04-30
Last updated
2023-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriopathy

Brief summary

Arteriopathy of the lower limbs (ALL) is defined by a decreased ankle perfusion pressure with a systolic pressure index (SPI) \<0.9, and constitutes the most advanced situation in terms of cardiovascular prognosis with in 20 % of cases of lesions associated with the heart and / or coronary heart. The severity of ALL is linked to the risk of a cardiovascular event, hence the need for a hemodynamic evaluation which is mainly based on the measurement of SPI.

Detailed description

However, the presence of mediacalcosis, making the arteries incompressible, limits the interpretation of IPS. However, ALL affects 50% of diabetic patients after 20 years of disease with predominant involvement in the infra-popliteal gland consisting mainly of mediacalcosis, but often respecting the arteries of the foot. The recommendations of the French-speaking Association for the Study of Diabetes and Metabolic Diseases in 1997 and of the American Diabetes Association in 2001, recommended the SPI and the realization of ultrasound for the diagnosis of ALL. Some authors have shown that SPI can be falsely normal with 4.3 times more false negative ankle SPI in diabetics compared to the general population. This is why this measurement of the SPI is coupled with the measurement of the pressure of the big toe (PGT) or even the transcutaneous measurement of the oxygen pressure (TcPO2) as recommended by the American Heart Association (AHA) and the American College of Cardiology (ACC) in 2005, in case of uninterpretable IPS. The subjects at risk of mediacalcosis are: diabetics, renal insufficiency and the very elderly. A recent thesis work confirmed that the SPI alone was not reliable as a screening tool in diabetic patients, with good sensitivity of the measurement of PGT. What about a population over the age of 70, without diabetes and without kidney failure?

Interventions

None listed

Sponsors

Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Man or woman aged\> 70 hospitalized in the vascular medicine department of the Paris Saint-Joseph Hospital Group * French-speaking patient

Exclusion criteria

* Patient with treated or untreated diabetes * Renal failure (GFR CKD-EPI or MDRD \<60ml / min) * ATCD revascularization or amputation * Patient under guardianship or curatorship * Patient deprived of liberty * Patient objecting to participation in the study * Patient under legal protection.

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the diagnostic performance of toe IPSI by laser-doppler, as a screening test for ALL in patients over 70 years of age, non-diabetic and non-renal failure, compared to the data of the considered Doppler ultrasound as the gold standardDay 1Sensitivity and specificity of laser-doppler toe PSI for screening ALL in patients over 70 years of age.

Secondary

MeasureTime frameDescription
Determination of the sex of the populationDay 1Sex
Number of participants with presence of hypertensionDay 1Presence of hypertension
Number of smokers among the participantsDay 1Tobacco
Number of participants with cardiovascular historyDay 1Cardiovascular history
Determination of the age of the populationDay 1Age
Relationship between toe SPI and risk factors for arterial disease of the lower limbsDay 1SPI toe values by subgroups of risk factors for arterial disease of the lower limbs
Relationship between ankle SPI and lower limb arterial disease risk factorsDay 1SPI ankle values by subgroups of risk factors for arterial disease of the lower limbs
Search for predictive factors associated with toe SPI for the diagnosis of arteriopathy of the lower limbsDay 1Predictors associated with toe PSI for the occurrence of lower limb arterial disease
Search for predictive factors associated with ankle SPI for the diagnosis of arteriopathy of the lower limbsDay 1Predictors associated with ankle PSI for the occurrence of lower limb arterial disease
Number of participants with treatmentsDay 1Treatments

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026