Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT05009602
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2021-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007511', 'term': 'Ischemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055109', 'term': 'Ankle Brachial Index'}], 'ancestors': [{'id': 'D001795', 'term': 'Blood Pressure Determination'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'l.burgess@imperial.ac.uk', 'phone': '0203 311 5208', 'title': 'Laura Burgess', 'organization': 'Imperial College London'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Reported during the study duration; approximately 6 weeks (from baseline until scan performed).', 'description': 'An AE is any untoward medical occurrence in a patient or clinical trial participant. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, whether or not considered related to the trial protocol.\n\nFor the purposes of the study, only AEs related to study procedures were recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'Diagnostic Test: Toe Brachial Pressure Index (TBPI) TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.\n\nDiagnostic Test: Ankle Brachial Pressure Index (ABPI) A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery.\n\nDiagnostic Test: Exercise Ankle Brachial Pressure Index (ABPI) A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing.\n\nDiagnostic Test: Audible handheld Doppler Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.\n\nDiagnostic Test: Visual handheld Doppler Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.\n\nDiagnostic Test: Podiatry Ankle Duplex scan (PAD-scan) Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.\n\nTo be used in 3 participating centers only.', 'otherNumAtRisk': 604, 'deathsNumAtRisk': 604, 'otherNumAffected': 4, 'seriousNumAtRisk': 604, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bilateral Leg pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'notes': 'Patient vomited after completing exercise ABPI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cramp and leg pain', 'notes': 'Cramp and leg pain after first visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg pain', 'notes': "Participant complained of left lower leg pain and leg 'occasionally giving way' for five days following index tests. Reports nothing since", 'stats': [{'groupId': 'EG000', 'numAtRisk': 604, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diagnostic Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}, {'value': '536', 'groupId': 'OG001'}, {'value': '521', 'groupId': 'OG002'}, {'value': '532', 'groupId': 'OG003'}, {'value': '480', 'groupId': 'OG004'}, {'value': '101', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Audible Doppler', 'description': 'Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.'}, {'id': 'OG001', 'title': 'Visual Doppler', 'description': 'Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.'}, {'id': 'OG002', 'title': 'Toe Brachial 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{'value': '536', 'groupId': 'OG001'}, {'value': '521', 'groupId': 'OG002'}, {'value': '532', 'groupId': 'OG003'}, {'value': '480', 'groupId': 'OG004'}, {'value': '101', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Audible Doppler', 'description': 'Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.'}, {'id': 'OG001', 'title': 'Visual Doppler', 'description': 'Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.'}, {'id': 'OG002', 'title': 'Toe Brachial Pressure Index (TBPI)', 'description': 'TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.'}, {'id': 'OG003', 'title': 'Ankle Brachial Pressure Index (ABPI)', 'description': 'A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the 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'lowerLimit': '0.5', 'upperLimit': '0.7'}, {'value': '0.7', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '0.8'}, {'value': '0.7', 'groupId': 'OG004', 'lowerLimit': '0.6', 'upperLimit': '0.8'}, {'value': '0.2', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '0.6'}]}]}, {'title': 'Positive Likelihood Ratio (PLR)', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '9.4'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '4.5'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '3.4'}, {'value': '2.6', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '3.8'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '1.6', 'upperLimit': '3.6'}, {'value': '2.9', 'groupId': 'OG005', 'lowerLimit': '1.7', 'upperLimit': '4.9'}]}]}, {'title': 'Odds Ratio (OR)', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '15.1'}, 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'counts': [{'value': '1000', 'groupId': 'OG000'}, {'value': '1000', 'groupId': 'OG001'}, {'value': '1000', 'groupId': 'OG002'}, {'value': '1000', 'groupId': 'OG003'}, {'value': '1000', 'groupId': 'OG004'}, {'value': '1000', 'groupId': 'OG005'}, {'value': '1000', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Audible Doppler', 'description': 'Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.'}, {'id': 'OG001', 'title': 'Visual Doppler', 'description': 'Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.'}, {'id': 'OG002', 'title': 'Toe Brachial Pressure Index (TBPI)', 'description': 'TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.'}, {'id': 'OG003', 'title': 'Ankle Brachial Pressure Index (ABPI)', 'description': 'A sphygmomanometer-cuff placed at the ankle and a 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'Participants', 'counts': [{'value': '603', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}, {'value': '603', 'groupId': 'OG002'}, {'value': '603', 'groupId': 'OG003'}, {'value': '603', 'groupId': 'OG004'}, {'value': '101', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Audible Doppler', 'description': 'Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.'}, {'id': 'OG001', 'title': 'Visual Doppler', 'description': 'Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.'}, {'id': 'OG002', 'title': 'Toe Brachial Pressure Index (TBPI)', 'description': 'TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.'}, {'id': 'OG003', 'title': 'Ankle Brachial Pressure Index (ABPI)', 'description': 'A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler 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'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Unsatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Neutral', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '77', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}]}, {'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '501', 'groupId': 'OG000'}, {'value': '503', 'groupId': 'OG001'}, {'value': '494', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}, {'value': '435', 'groupId': 'OG004'}, {'value': '77', 'groupId': 'OG005'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour: all index tests will be performed on the same day of presentation.', 'description': 'Patients will be asked to rate their experience of each index test on a Likert scale.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant that underwent the index test'}, {'type': 'SECONDARY', 'title': 'Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '603', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}, {'value': '603', 'groupId': 'OG002'}, {'value': '603', 'groupId': 'OG003'}, {'value': '603', 'groupId': 'OG004'}, {'value': '103', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Audible Doppler', 'description': 'Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.'}, {'id': 'OG001', 'title': 'Visual Doppler', 'description': 'Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.'}, {'id': 'OG002', 'title': 'Toe Brachial Pressure Index (TBPI)', 'description': 'TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.'}, {'id': 'OG003', 'title': 'Ankle Brachial Pressure Index (ABPI)', 'description': 'A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery.'}, {'id': 'OG004', 'title': 'Exercise Ankle Brachial Pressure Index (ABPI)', 'description': 'A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing.'}, {'id': 'OG005', 'title': 'Podiatry Ankle Duplex Scan (PAD-scan)', 'description': 'Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.\n\nUsed in 3 participating centers only.'}], 'classes': [{'title': 'Assessment performed - yes', 'categories': [{'measurements': [{'value': '603', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}, {'value': '590', 'groupId': 'OG002'}, {'value': '599', 'groupId': 'OG003'}, {'value': '540', 'groupId': 'OG004'}, {'value': '102', 'groupId': 'OG005'}]}]}, {'title': 'Assessment performed - no', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Assessment discontinued - yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Assessment discontinued - no', 'categories': [{'measurements': [{'value': '603', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}, {'value': '586', 'groupId': 'OG002'}, {'value': '596', 'groupId': 'OG003'}, {'value': '533', 'groupId': 'OG004'}, {'value': '102', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.', 'description': 'Inability to perform, refusal and discontinuation of tests will be documented', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Recruited participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Diagnostic Test: Toe Brachial Pressure Index (TBPI) TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.\n\nDiagnostic Test: Ankle Brachial Pressure Index (ABPI) A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery.\n\nDiagnostic Test: Exercise Ankle Brachial Pressure Index (ABPI) A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing.\n\nDiagnostic Test: Audible handheld Doppler Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.\n\nDiagnostic Test: Visual handheld Doppler Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.\n\nDiagnostic Test: Podiatry Ankle Duplex scan (PAD-scan) Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.\n\nTo be used in 3 participating centers only.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '604'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '536'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}]}]}], 'preAssignmentDetails': 'Patients are assessed for eligibility and some are excluded as per eligibility criteria'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '603', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Diagnostic Test: Toe Brachial Pressure Index (TBPI) TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.\n\nDiagnostic Test: Ankle Brachial Pressure Index (ABPI) A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery.\n\nDiagnostic Test: Exercise Ankle Brachial Pressure Index (ABPI) A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing.\n\nDiagnostic Test: Audible handheld Doppler Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.\n\nDiagnostic Test: Visual handheld Doppler Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.\n\nDiagnostic Test: Podiatry Ankle Duplex scan (PAD-scan) Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.\n\nTo be used in 3 participating centers only.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.48', 'spread': '12.78', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '215', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '388', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '429', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}, {'title': 'Mixed race / multiple ethnic background', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Other ethnic group', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes mellitus type', 'classes': [{'title': 'Type 1', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}]}]}, {'title': 'Type 2', 'categories': [{'measurements': [{'value': '480', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous history of diabetic foot ulcer', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '595', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Leg pain at rest', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '165', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '438', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Leg pain whilst exercising', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '157', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '446', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gangrene', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '595', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Foot examination - ulceration', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '521', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Foot examination - Infection', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '576', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Foot examination - Neuropathy present in index limb', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '148', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '455', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Overall WIfI Score', 'classes': [{'title': 'Very Low', 'categories': [{'measurements': [{'value': '564', 'groupId': 'BG000'}]}]}, {'title': 'Low', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'High', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Foot examination (neuropathy, pedal pulse examination, presence of diabetic foot ulcer (DFU), DFU severity using the WIfI (Wound, Ischemia, foot Infection) classification system.\n\nCategories are very low, low, moderate and high - referring to the risk of amputation at 1 year.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics for 603 participants that underwent baseline index tests'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-29', 'size': 1032926, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-11T07:25', 'hasProtocol': True}, {'date': '2023-11-14', 'size': 468899, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-11T07:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 604}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2021-08-04', 'resultsFirstSubmitDate': '2025-06-17', 'studyFirstSubmitQcDate': '2021-08-11', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-13', 'studyFirstPostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Accuracy', 'timeFrame': '6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.', 'description': 'Diagnostic accuracy of the PAD-scan and other bedside tests will be compared to the results of a Magnetic resonance angiograph (MRA) or Computed tomography angiography (CTA) (reference test).'}, {'measure': 'Diagnostic Accuracy - Ratios', 'timeFrame': '6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.', 'description': 'Diagnostic accuracy of the PAD-scan and other bedside tests will be compared to the results of a Magnetic resonance angiograph (MRA) or Computed tomography angiography (CTA) (reference test).'}], 'secondaryOutcomes': [{'measure': 'Health Economic Outcome - Cost Effectiveness', 'timeFrame': '5 years', 'description': 'Incremental cost-effectiveness ratio at 5 years.'}, {'measure': 'Health Economic Outcome - Cost Effectiveness (QALY)', 'timeFrame': '5 years', 'description': 'Incremental cost-effectiveness ratio at 5 years.'}, {'measure': 'Patient Acceptability', 'timeFrame': '1 hour: all index tests will be performed on the same day of presentation.', 'description': 'Patients will be asked to rate their experience of each index test on a Likert scale.'}, {'measure': 'Technical Success', 'timeFrame': '6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.', 'description': 'Inability to perform, refusal and discontinuation of tests will be documented'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Foot', 'Peripheral Arterial Disease', 'Diabetic Foot Ulcer', 'Peripheral Vascular Diseases', 'Peripheral Artery Disease', 'Critical Limb Ischemia', 'Critical Lower Limb Ischemia']}, 'referencesModule': {'references': [{'pmid': '36328388', 'type': 'DERIVED', 'citation': 'Normahani P, Burgess L, Norrie J, Epstein DM, Kandiyil N, Saratzis A, Smith S, Khunti K, Edmonds M, Ahluwalia R, Coward T, Hartshorne T, Ashwell S, Shalhoub J, Pigott E, Davies AH, Jaffer U; DM PAD study investigators. Study protocol for a multicentre comparative diagnostic accuracy study of tools to establish the presence and severity of peripheral arterial disease in people with diabetes mellitus: the DM PAD study. BMJ Open. 2022 Nov 3;12(11):e066950. doi: 10.1136/bmjopen-2022-066950.'}]}, 'descriptionModule': {'briefSummary': 'In the UK there are over 7,000 leg amputations each year because of diabetes. The most important cause of this is poor circulation. The detection of poor circulation in patients with diabetes is difficult. A number of tests exist to detect poor circulation (known as peripheral arterial disease (PAD)). However, there is confusion as to which is the gold standard.\n\nThe DM PAD study aims to determine the diagnostic performance of index tests (audible handheld Doppler, visual handheld Doppler, ankle brachial pressure index (ABPI), exercise ABPI and toe brachial pressure index (TBPI)) for the diagnosis of PAD in patients with diabetes as determined by a reference test (CTA or MRA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with a diagnosis of diabetes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥18 years\n* Known history of diabetes\n\nExclusion Criteria:\n\n* PAD status known on imaging\n* Known history of PAD intervention\n* CTA and MRA contraindications- renal impairment, pregnancy, contrast medium hypersensitivity/allergy, non-compatible implants (MRA only).\n* Unable to provide appropriate informed consent.'}, 'identificationModule': {'nctId': 'NCT05009602', 'acronym': 'DM PAD', 'briefTitle': 'Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes', 'orgStudyIdInfo': {'id': '21CX7046'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participating Centre', 'description': 'To complete all index tests and reference scan', 'interventionNames': ['Diagnostic Test: Toe Brachial Pressure Index (TBPI)', 'Diagnostic Test: Ankle Brachial Pressure Index (ABPI)', 'Diagnostic Test: Exercise Ankle Brachial Pressure Index (ABPI)', 'Diagnostic Test: Audible handheld Doppler', 'Diagnostic Test: Visual handheld Doppler', 'Diagnostic Test: Podiatry Ankle Duplex scan (PAD-scan)']}], 'interventions': [{'name': 'Toe Brachial Pressure Index (TBPI)', 'type': 'DIAGNOSTIC_TEST', 'description': 'TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.', 'armGroupLabels': ['Participating Centre']}, {'name': 'Ankle Brachial Pressure Index (ABPI)', 'type': 'DIAGNOSTIC_TEST', 'description': 'A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery.', 'armGroupLabels': ['Participating Centre']}, {'name': 'Exercise Ankle Brachial Pressure Index (ABPI)', 'type': 'DIAGNOSTIC_TEST', 'description': 'A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing.', 'armGroupLabels': ['Participating Centre']}, {'name': 'Audible handheld Doppler', 'type': 'DIAGNOSTIC_TEST', 'description': 'Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.', 'armGroupLabels': ['Participating Centre']}, {'name': 'Visual handheld Doppler', 'type': 'DIAGNOSTIC_TEST', 'description': 'Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.', 'armGroupLabels': ['Participating Centre']}, {'name': 'Podiatry Ankle Duplex scan (PAD-scan)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.\n\nTo be used in 3 participating centers only.', 'armGroupLabels': ['Participating Centre']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SS16 5NL', 'city': 'Basildon', 'country': 'United Kingdom', 'facility': 'Mid and South Essex NHS Foundation Trust', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'zip': 'CF14 4XW', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Cardiff and Vale UHB', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'DE22 3NE', 'city': 'Derby', 'country': 'United Kingdom', 'facility': 'University Hospitals of Derby and Burton NHS Foundation Trust', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'G12 0XH', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'NHS Greater Glasgow and Clyde', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'HU3 2JZ', 'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Hull University Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'University Hospitals of Leicester NHS Trust', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'NW1 5JD', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Central London Community Healthcare NHS Trust sites', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW10 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea and Westminster Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW17 0QT', 'city': 'London', 'country': 'United Kingdom', 'facility': "St George's University Hospitals NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W6 8RF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith and Fulham Partnership', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'South Tees Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals (NUH) NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'OX4 2PG', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'University Hospitals Plymouth NHS Trust', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'University Hospitals Southampton NHS Foundation Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'WR5 1DD', 'city': 'Worcester', 'country': 'United Kingdom', 'facility': 'Worcestershire Acute Hospitals NHS Trust', 'geoPoint': {'lat': 52.18935, 'lon': -2.22001}}], 'overallOfficials': [{'name': 'Usman Jaffer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Leicester', 'class': 'OTHER'}, {'name': 'University of Edinburgh', 'class': 'OTHER'}, {'name': 'Universidad de Granada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}