Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2025-12-30 @ 9:54 AM
Study NCT ID:
NCT07229794
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Foot-ankle Exercise Using Elastic Band
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}], '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': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-01', 'size': 110953, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-07T14:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diabetic foot ulcer (DFU) incidence', 'timeFrame': 'for a year', 'description': 'DFU, defined as a wound in the area below the ankle that reaches at least the epidermis and part of the dermis, as diagnosed by an internist'}], 'secondaryOutcomes': [{'measure': 'diabetic neuropathy examination score', 'timeFrame': '0, 12 weeks, and a year', 'description': 'The accumulation score of the result measurement consists of eight item, two testing muscle strength, one a tendon reflex, and five sensation. The min-max score is 0-16. The higher the score indicates the more severe the neuropathy. The score was determined by doing a physical examination.'}, {'measure': 'control glyacemic', 'timeFrame': '0, 12 weeks, and a year', 'description': 'HbA1c levels, which are the level of blood sugar control over a period of time. 3 months, measured by analyzing blood serum in a laboratory using the National Glycohemoglobin Standardization Program (NGSP).'}, {'measure': 'brain derived neurotrophic factor', 'timeFrame': '0, 12 weeks, and a year', 'description': 'BDNF levels, which are defined as biomolecular markers that can indicate the severity of diabetic neuropathy, as measured by analyzing blood serum using the ELIZA technique'}, {'measure': 'walking speed', 'timeFrame': '0, 12 weeks, and a year', 'description': 'Walking speed is the ratio between times measured while walking in second as fast as possible on a flat and flat trajectory at a certain distance. A track distance used in the study was 5 meter. The time of waking was measured using stopwatch'}, {'measure': 'foot ankle range of motion', 'timeFrame': '0, 12 weeks, and a year', 'description': 'ankle range of motion, which is the degree of joint movement in the feet during flexion, extension, inversion, and eversion, as measured using digital goniometry'}, {'measure': 'callus insidence', 'timeFrame': '0, 12 weeks, and a year', 'description': 'Callus is the thickness of the plantar skin area that can be determined by inspection'}, {'measure': 'neuropathy symptom score', 'timeFrame': '0, 12 weeks, and a year', 'description': 'The accumulation score of the result measurement consists of sixteen item about the symptom of neuropathy. The min-max score is 0-16. The more score indicates the more severe of neuropathy. The score was determined by interviewing the patient'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetic foot ulcer', 'diabetes mellitus', 'foot ankle exercise', 'neuropathy diabetes'], 'conditions': ['Diabetic Foot Ulcer (DFU)', 'Neuropathy (Disorder)']}, 'referencesModule': {'references': [{'pmid': '28614678', 'type': 'BACKGROUND', 'citation': 'Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if foot-ankle exercise can prevent diabetic foot ulcer incidence in patient with diabetes neuropathy. It will also learn about the effect of foot-ankle exercise on improvement of diabetes neuropathy severity, glycemic control, brain-derived neurotropic factor, walking speed, foot ankle range of motion, callus. The main questions it aims to answer are:\n\n* Does foot-ankle exercise lower the number of diabetic ulcer incidence\n* Does foot-ankle exercise lower the diabetes neuropathy severity\n* Does foot-ankle exercise improve glycemic control\n* Does foot-ankle exercise improve brain-derived neurotrophic factor\n* Does foot-ankle exercise improve walking speed\n* Does foot-ankle exercise improve foot ankle range of motion\n* Does foot-ankle exercise lower the number of callus incidence', 'detailedDescription': 'Researchers will compare intervention group foot-ankle exercise used elastic band to a control group to see if foot-ankle exercise work to prevent diabetic foot ulcer incidence in patient with diabetes neuropathy\n\nParticipants will:\n\n* Do foot-ankle exercise for three times a week with non-consecutive day for 1 year\n* Report the incidence of callus and diabetic foot ulcer whenever they have'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes\n* can walk minimal 10 meters\n* neuropathy diabetic\n\nExclusion Criteria:\n\n* stroke\n* active ulcer\n* fracture on foot area\n* diabetic ulcer history'}, 'identificationModule': {'nctId': 'NCT07229794', 'briefTitle': 'Effect of Foot-ankle Exercise Using Elastic Band', 'organization': {'class': 'OTHER', 'fullName': 'St Elisabeth School Health Science'}, 'officialTitle': 'Effect of Foot-ankle Exercise Using Elastic Band on Diabetic Foot Ulcer Incidence in Patient With Diabetes Neuropathy', 'orgStudyIdInfo': {'id': 'Stikes Elisabeth11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'foot-ankle exercise group', 'description': 'The group will receive usual care with additional food-ankle exercises using elastic band supervised by professional health care three times a week for twelve weeks. After twelve weeks period the patient will continue exercising for the completion of the study (9 month) by them self with the help of foot-ankle exercise video.', 'interventionNames': ['Other: foot-ankle exercise']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Patient will receive usual care, with include pharmacological treatment and self care guidelines, which are maintained in both group'}], 'interventions': [{'name': 'foot-ankle exercise', 'type': 'OTHER', 'description': 'The exercise was done 3 times a week (15x/until they tired x 2set). The exercise used a elastic band with difference thickness (0,5 mm in 12 weeks and 0,65 mm in nine month)', 'armGroupLabels': ['foot-ankle exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50231', 'city': 'Semarang', 'state': 'Central Java', 'country': 'Indonesia', 'facility': 'Elisabeth clinic', 'geoPoint': {'lat': -6.99306, 'lon': 110.42083}}], 'overallOfficials': [{'name': 'maria suryani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'stikes elisabeth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St Elisabeth School Health Science', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Maria Suryani', 'investigatorAffiliation': 'St Elisabeth School Health Science'}}}}