Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-05 @ 5:48 AM
Study NCT ID:
NCT03380403
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2017-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial Testing the Efficacy of PDT in Preventing Amputation in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010019', 'term': 'Osteomyelitis'}, {'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'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': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C008848', 'term': '1-phenyl-3,3-dimethyltriazene'}, {'id': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'non-randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-26', 'studyFirstSubmitDate': '2017-11-24', 'studyFirstSubmitQcDate': '2017-12-15', 'lastUpdatePostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infection control', 'timeFrame': 'every month until three months , when blood count- leucocytes reach the standard value.', 'description': 'blood count - leucocytes for infection'}], 'secondaryOutcomes': [{'measure': 'Osteomyelitis evaluation', 'timeFrame': 'once a month, until three months, when X-ray shows bone reconstitution .', 'description': 'Radiographs were used when patients presented osteomyelitis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetic foot', 'Osteomyelitis', 'PACT', 'PDT', 'Singlet oxygen', 'antimicrobial', 'diabetes', 'Wagner scale'], 'conditions': ['Diabetic Foot Infection', 'Osteomyelitis', 'Photo Antimicrobial Chemotherapy']}, 'referencesModule': {'references': [{'pmid': '27884621', 'type': 'BACKGROUND', 'citation': 'Wainwright M, Maisch T, Nonell S, Plaetzer K, Almeida A, Tegos GP, Hamblin MR. Photoantimicrobials-are we afraid of the light? Lancet Infect Dis. 2017 Feb;17(2):e49-e55. doi: 10.1016/S1473-3099(16)30268-7. Epub 2016 Nov 22.'}, {'pmid': '26281044', 'type': 'BACKGROUND', 'citation': 'Tardivo JP, Baptista MS, Correa JA, Adami F, Pinhal MA. Development of the Tardivo Algorithm to Predict Amputation Risk of Diabetic Foot. PLoS One. 2015 Aug 17;10(8):e0135707. doi: 10.1371/journal.pone.0135707. eCollection 2015.'}, {'pmid': '26862179', 'type': 'RESULT', 'citation': 'Abrahamse H, Hamblin MR. New photosensitizers for photodynamic therapy. Biochem J. 2016 Feb 15;473(4):347-64. doi: 10.1042/BJ20150942.'}, {'pmid': '26160556', 'type': 'RESULT', 'citation': 'Sahu K, Sharma M, Dube A, Gupta PK. Topical antimicrobial photodynamic therapy improves angiogenesis in wounds of diabetic mice. Lasers Med Sci. 2015 Sep;30(7):1923-9. doi: 10.1007/s10103-015-1784-8. Epub 2015 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'The feet of diabetic patients continue to be an important problem in medicine. In general, patients with diabetic foot have some sort of amputation, especially in underserved populations. It is clearly necessary to develop novel treatment strategies for this worldwide health problem. Photodynamic therapy (PDT) , is a low cost and highly effective alternative treatment concerning infections avoiding amputations in the diabetic foot.', 'detailedDescription': 'Patients with infected diabetic foot were grouped according to the Wagner system for classifying foot lesions. All patients presented Wagner Grade 3 classification, with osteomyelitis in one or more toes. The study included only patients who had circulatory viability.\n\nFor PDT treatment the fistula and/or ulcer was used as a gateway to the bone. The treated area (bones and fingers) was irrigated with a solution of phenothiazinium salts. After that, light irradiation was performed with optical fibers or led device above the wound. PDT treatment always in outpatients, once or twice a week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '83 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years old\n* diabetes\n* diabetic foot\n* Wagner grade III\n\nExclusion Criteria:\n\n* age \\< 18 years old\n* non-diabetic\n* Wagner IV and V\n* ischemia'}, 'identificationModule': {'nctId': 'NCT03380403', 'briefTitle': 'A Clinical Trial Testing the Efficacy of PDT in Preventing Amputation in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Faculdade de Medicina do ABC'}, 'officialTitle': 'A Clinical Trial Testing the Efficacy of PDT in Preventing Amputation in Diabetic Patients', 'orgStudyIdInfo': {'id': 'Faculdade de medicina do ABC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PDT', 'description': 'Methylene blue and Photon Irradiation , every each week, until total ulcer healing.', 'interventionNames': ['Radiation: PDT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ciprofloxacin', 'description': 'Diabetic foot patients were treated on conventional way, using antibiotics and surgery.', 'interventionNames': ['Other: Ciprofloxacin']}], 'interventions': [{'name': 'PDT', 'type': 'RADIATION', 'otherNames': ['photoantimicrobial chemotherapy'], 'description': 'clinical treatment of infected diabetic foot', 'armGroupLabels': ['PDT']}, {'name': 'Ciprofloxacin', 'type': 'OTHER', 'otherNames': ['Conventional treatment'], 'description': 'antibiotics and or surgical debridment', 'armGroupLabels': ['Ciprofloxacin']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculdade de Medicina do ABC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'João Paulo Tardivo', 'investigatorAffiliation': 'Faculdade de Medicina do ABC'}}}}