Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-03-09 @ 12:25 PM
Study NCT ID:
NCT05941533
Status:
UNKNOWN
Last Update Posted:
2023-07-18
First Post:
2023-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infrared Thermal Imaging in Evaluating the Percutaneous Transluminal Angioplasty for Peripheral Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-16', 'studyFirstSubmitDate': '2023-07-04', 'studyFirstSubmitQcDate': '2023-07-04', 'lastUpdatePostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the validity and reliability of IRTI in assessing foot blood perfusion and surgical success rate after PTA treatment.', 'timeFrame': 'up to 15 months', 'description': 'The different levels of pseudocodes (white, red, pink, yellow, green, blue, and black) represent the corresponding IRTI, corresponding to the color bar from low to high temperature.\n\nWe will measure the average temperature of the dorsum and sole of the foot before and after PTA treatment in the operated and non-operated limbs. Ankle-brachial index (ABI) of the operated and non-operated limbs before and after PTA treatment will also be measured.\n\nWe will analyze the agreement between ABI and foot temperature in the operated and non-operated limbs, as well as the agreement between the change in ABI and foot temperature.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['peripheral artery disease (PAD), infrared thermal imaging (IRTI), percutaneous transluminal angioplasty (PTA)'], 'conditions': ['Peripheral Artery Disease (PAD)']}, 'descriptionModule': {'briefSummary': 'Determination of IRTI (infrared thermal imaging) can be used to evaluate PAD patients with critical limb ischemia with different degrees of lesion.\n\nIRTI can be used to evaluate the foot blood perfusion after percutaneous transluminal angioplasty (PTA) treatment and determine the success rate of surgery.\n\nIRTI can be used as an effective follow-up tool for patients after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'PAD patients who came to our hospital for diagnosis and treatment were initially selected, and those who met the indications for PTA surgery were finally included in the study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Rutherford grade 3, 4, 5, or 6.\n* Patients with indications for lower extremity arterial PTA: severe intermittent claudication, rest pain, ulceration or gangrene.\n* Patients who required PTA of only one limb (left versus right).\n\nExclusion Criteria:\n\n* Patients with body temperature above 37 ° C.\n* Patients with indications for open surgery.\n* Patients requiring major amputation (above the ankle).\n* Patients with acute occlusive or embolic limb ischemia.\n* Patients with deep venous thrombosis of the lower extremity.'}, 'identificationModule': {'nctId': 'NCT05941533', 'briefTitle': 'Infrared Thermal Imaging in Evaluating the Percutaneous Transluminal Angioplasty for Peripheral Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'Infrared Thermal Imaging in Evaluating the Percutaneous Transluminal Angioplasty for Peripheral Artery Disease', 'orgStudyIdInfo': {'id': 'IRTIPTA'}}, 'contactsLocationsModule': {'locations': [{'zip': '510163', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fangge Deng, Researcher', 'role': 'CONTACT', 'email': 'fangge256@sina.com', 'phone': '86 13234006746'}], 'facility': 'Fangge Deng', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fangge Deng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': ': Principal Investigator', 'investigatorFullName': 'Fangge Deng', 'investigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}}}}