Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-31 @ 7:14 PM
Study NCT ID:
NCT05408234
Status:
UNKNOWN
Last Update Posted:
2022-06-07
First Post:
2022-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modified Foot Exercise to Improve Sensitivity and Perfussion on Type 2 Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study was conducted in the control and treatment groups where the control group will get the treatment of doing modified leg exercises for one week. The control group did not get the modified leg exercise. Both groups received standard therapy for type 2 diabetes.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-01', 'studyFirstSubmitDate': '2022-06-01', 'studyFirstSubmitQcDate': '2022-06-01', 'lastUpdatePostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting Blood Glucose', 'timeFrame': 'Cange Fasting Blood Glucose in 1 weeks', 'description': 'Fasting Blood Glucose'}, {'measure': 'Monofilament test', 'timeFrame': 'Cange monofilament test in 1 weeks', 'description': 'Monofilament test to detect diabetic neuropathy'}, {'measure': 'Ankle Brachial Index', 'timeFrame': 'Cange Ankle Brachial Index in 1 weeks', 'description': 'Ankle Brachial Index'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['foot exercise, Diabetes Mellitus type 2'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Subject will be trained to do regular foot exercise during their visit to the clinic. We will evaluate foot sensitivity and peripheral perfussion after', 'detailedDescription': 'Use an 8-10 MHz Doppler probe with a gel smeared over the sensor. Place the Doppler probe on the pulse area at a 45-60° angle to the skin surface.\n\nMove the probe to find the most precise and robust arterial pulse before inflating the cuff.\n\nThe cuff is inflated about 20 mm Hg above the point where the arterial Doppler sound disappears.\n\nThen slowly deflate until the Doppler sound reappears and records this value. The blood pressure at which the arterial pulse reappears is the systolic pressure for that blood vessel.\n\nIf the flow is still detected at the maximum inflation rate (300 mmHg), the cuff should be deflated immediately to avoid pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes Mellitus Type 2\n\nExclusion Criteria:\n\n* Chronic Heart Failure\n* Chronic Kidney Diseae'}, 'identificationModule': {'nctId': 'NCT05408234', 'briefTitle': 'Modified Foot Exercise to Improve Sensitivity and Perfussion on Type 2 Diabetes Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Sebelas Maret'}, 'officialTitle': 'Modified Foot Exercise to Improve Peripheral Perfussion and Sensitivity on Type 2 Diabetes Patients', 'orgStudyIdInfo': {'id': 'FootExercise'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smart Foot Exercise', 'description': 'The patient lies supine (supine) with the legs raised 450 while supported for 1-3 minutes until blanching occurs (the skin becomes pale).\n\nThe patient sits on the edge of the bed with the legs hanging down and then performs dorsiflexion, plantarflexion, inversion, and eversion for 3 minutes until the skin appears red.\n\nThe patient lies supine with the legs covered with a blanket for 3-5 minutes. This whole cycle is repeated 3-6 times per session, and each session is repeated 2-4 times a day.\n\nMovement using newspaper media, namely by:\n\nPlace a sheet of newspaper on the floor, then shape the sheet into a ball with both feet.\n\nThe ball shape is then opened into a sheet as before with both feet. Tear the newspaper into two parts, and separate the two parts of the newspaper. Tear the first newspaper into small pieces with both feet. Remove the bunch of stubs and place them in a second, whole newspaper. Wrap everything into a ball shape with both feet. This step is enough to do once.', 'interventionNames': ['Other: Smart Foot Exercise']}], 'interventions': [{'name': 'Smart Foot Exercise', 'type': 'OTHER', 'description': 'The patient lies supine (supine) with the legs raised 450 while supported for 1-3 minutes until blanching occurs (the skin becomes pale).\n\nThe patient sits on the edge of the bed with the legs hanging down and then performs dorsiflexion, plantarflexion, inversion, and eversion for 3 minutes until the skin appears red.\n\nThe patient lies supine with the legs covered with a blanket for 3-5 minutes. This whole cycle is repeated 3-6 times per session, and each session is repeated 2-4 times a day.\n\nMovement using newspaper media, namely by:\n\nPlace a sheet of newspaper on the floor, then shape the sheet into a ball with both feet.\n\nThe ball shape is then opened into a sheet as before with both feet. Tear the newspaper into two parts, and separate the two parts of the newspaper. Tear the first newspaper into small pieces with both feet. Remove the bunch of stubs and place them in a second, whole newspaper. Wrap everything into a ball shape with both feet. This step is enough to do once.', 'armGroupLabels': ['Smart Foot Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57145', 'city': 'Surakarta', 'state': 'Central Java', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Nurhasan Agung Prabowo, MD', 'role': 'CONTACT', 'email': 'dr.Nurhasan21@staff.uns.ac.id', 'phone': '082328010430'}], 'facility': 'RS UNS (Universitas Sebelas Maret Hospital)', 'geoPoint': {'lat': -7.55611, 'lon': 110.83167}}], 'centralContacts': [{'name': 'Nurhasan Agung Prabowo, MD', 'role': 'CONTACT', 'email': 'dr.Nurhasan21@staff.uns.ac.id', 'phone': '6282328010430'}], 'overallOfficials': [{'name': 'Nurhasan Agung Prabowo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitas Sebelas Maret'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Sebelas Maret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Nurhasan Agung Prabowo', 'investigatorAffiliation': 'Universitas Sebelas Maret'}}}}