Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 12:07 PM
Study NCT ID:
NCT01681160
Status:
COMPLETED
Last Update Posted:
2012-09-10
First Post:
2012-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Maggot Therapy in Diabetic Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000096383', 'term': 'Maggot Debridement Therapy'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-07', 'studyFirstSubmitDate': '2012-09-04', 'studyFirstSubmitQcDate': '2012-09-06', 'lastUpdatePostDateStruct': {'date': '2012-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 3days and change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 6 days', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MAGGOT THERAPY', 'DIABETIC FOOT', 'NURSING CARE', 'DRESSING'], 'conditions': ['DIABETIC FOOT ULCERS']}, 'descriptionModule': {'briefSummary': 'This study was a Kind of clinical trial with equal randomization, that have been done from January 2009 to June 2011 in the AFZALIPOOR hospital endocrine ward in Kerman-Iran on 128 diabetic patient who had foot wounds.Replacement of conventional therapy by new methodes is one of the more important aims for health professional specially for nurses.One of this new treatment is maggot therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a chronic illness more than 7 weeks.\n* The age of the patients between 40- 90 years old.\n* Not having capillary disease (Blockage of artery, Rinold).\n* Not user of anticoagulants and corticosteroids drugs.\n* Patients without history of allergy to drugs and foods.\n* Having diabetic type 2\n\nExclusion Criteria:\n\n* patients who refer to critical clinical care unit\n* patients who have amputation'}, 'identificationModule': {'nctId': 'NCT01681160', 'acronym': 'MDT', 'briefTitle': 'Study of Maggot Therapy in Diabetic Foot Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'Kerman Medical University'}, 'officialTitle': 'Maggot Therapy in Diabetic Foot Ulcers', 'orgStudyIdInfo': {'id': '86/116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MAGGOT THERAPY & conventional therapy T', 'description': 'Maggot therapy,ADMINISTERED TWO TIMES AS A NEW METHODS OF DRESSING in experimental group.conventional therapy ,administered two times in control group', 'interventionNames': ['Other: procedure:maggot therapy', 'Other: conventional therapy']}], 'interventions': [{'name': 'procedure:maggot therapy', 'type': 'OTHER', 'otherNames': ['larval therapy'], 'description': 'each times in maggot therapy continued for three days.wound assessment was done before and after any intervention', 'armGroupLabels': ['MAGGOT THERAPY & conventional therapy T']}, {'name': 'conventional therapy', 'type': 'OTHER', 'otherNames': ['mechanical debridement'], 'description': 'patients receive ordinary treatment for diabetic foot', 'armGroupLabels': ['MAGGOT THERAPY & conventional therapy T']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kerman Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'university instructor', 'investigatorFullName': 'Forough Pouryazdanpanah Kermani', 'investigatorAffiliation': 'Kerman Medical University'}}}}