Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-02 @ 10:28 PM
Study NCT ID:
NCT04794192
Status:
UNKNOWN
Last Update Posted:
2023-03-07
First Post:
2021-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Ankle Systolic Pressure Index in Patients Over 70 Years of Age With Jaundice Ulcer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2021-03-05', 'studyFirstSubmitQcDate': '2021-03-09', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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 standard', 'timeFrame': 'Day 1', 'description': 'Sensitivity and specificity of laser-doppler toe PSI for screening ALL in patients over 70 years of age.'}], 'secondaryOutcomes': [{'measure': 'Determination of the age of the population', 'timeFrame': 'Day 1', 'description': 'Age'}, {'measure': 'Determination of the sex of the population', 'timeFrame': 'Day 1', 'description': 'Sex'}, {'measure': 'Number of participants with presence of hypertension', 'timeFrame': 'Day 1', 'description': 'Presence of hypertension'}, {'measure': 'Number of smokers among the participants', 'timeFrame': 'Day 1', 'description': 'Tobacco'}, {'measure': 'Number of participants with cardiovascular history', 'timeFrame': 'Day 1', 'description': 'Cardiovascular history'}, {'measure': 'Number of participants with treatments', 'timeFrame': 'Day 1', 'description': 'Treatments'}, {'measure': 'Relationship between toe SPI and risk factors for arterial disease of the lower limbs', 'timeFrame': 'Day 1', 'description': 'SPI toe values by subgroups of risk factors for arterial disease of the lower limbs'}, {'measure': 'Relationship between ankle SPI and lower limb arterial disease risk factors', 'timeFrame': 'Day 1', 'description': 'SPI ankle values by subgroups of risk factors for arterial disease of the lower limbs'}, {'measure': 'Search for predictive factors associated with toe SPI for the diagnosis of arteriopathy of the lower limbs', 'timeFrame': 'Day 1', 'description': 'Predictors associated with toe PSI for the occurrence of lower limb arterial disease'}, {'measure': 'Search for predictive factors associated with ankle SPI for the diagnosis of arteriopathy of the lower limbs', 'timeFrame': 'Day 1', 'description': 'Predictors associated with ankle PSI for the occurrence of lower limb arterial disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arteriopathy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe subjects at risk of mediacalcosis are: diabetics, renal insufficiency and the very elderly.\n\nA 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.\n\nWhat about a population over the age of 70, without diabetes and without kidney failure?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged\\> 70 hospitalized in the vascular medicine department of the Paris Saint-Joseph Hospital Group', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man or woman aged\\> 70 hospitalized in the vascular medicine department of the Paris Saint-Joseph Hospital Group\n* French-speaking patient\n\nExclusion Criteria:\n\n* Patient with treated or untreated diabetes\n* Renal failure (GFR CKD-EPI or MDRD \\<60ml / min)\n* ATCD revascularization or amputation\n* Patient under guardianship or curatorship\n* Patient deprived of liberty\n* Patient objecting to participation in the study\n* Patient under legal protection.'}, 'identificationModule': {'nctId': 'NCT04794192', 'acronym': 'IPScheville', 'briefTitle': 'Assessment of the Ankle Systolic Pressure Index in Patients Over 70 Years of Age With Jaundice Ulcer', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Assessment of the Ankle Systolic Pressure Index in Patients Over 70 Years of Age With Jaundice Ulcer', 'orgStudyIdInfo': {'id': 'IPS cheville'}}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Groupe Hospitalier Paris Saint-Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Raphaël ATTAL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Hôpital Saint-Joseph'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}