Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-29 @ 12:39 AM
Study NCT ID:
NCT07043868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-10
First Post:
2025-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects and Feasibility of Photobiomodulation at 830nm Nanometers in the Treatment of Diabetic Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D017719', 'term': 'Diabetic Foot'}], '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'}, {'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': 'D003929', 'term': 'Diabetic Neuropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-05', 'studyFirstSubmitDate': '2025-06-21', 'studyFirstSubmitQcDate': '2025-06-21', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ulcer area reduction rate', 'timeFrame': 'Pre-intervention, five weeks and ten weeks of treatment', 'description': 'The ulcers will be measured with a paper ruler and photographed for later analysis of the images using the ImageJ program. The paper ruler will be positioned to measure the length and width of the ulcers.'}], 'secondaryOutcomes': [{'measure': 'University of Texas Rankings', 'timeFrame': 'Pre-intervention, five weeks and ten weeks of treatment', 'description': 'For analysis of ulcer depth, volunteers will be grouped into A1 and C1 (superficial ulcers), A2 and C2 (ulcers involving tendon or joint capsule) and A3 (ulcers involving bone).'}, {'measure': 'Quality of life assessment', 'timeFrame': 'Pre-intervention, five weeks and ten weeks of treatment', 'description': 'The EQ-5D tool will be used, consisting of five questions that assess the following aspects: mobility, personal care, usual activities, pain or discomfort, and anxiety/depression.'}, {'measure': 'Glycemic level assessment', 'timeFrame': 'Once a week for ten weeks (20 sessions)', 'description': "Volunteers' blood glucose levels will be checked once a week throughout treatment."}, {'measure': 'Analysis of healing time and recurrence rate', 'timeFrame': 'Quarterly follow-up (3 months) after initial healing', 'description': 'Healing time:Difference, in days, between the date of the first clinical record of the lesion and the date on which the wound is considered fully healed, characterized by complete epithelialization, absence of secretion and necrotic tissue.Recurrence: assessed based on the difference, in days, between the date of complete healing and the record of recurrence of the lesion in the same region, major amputation, death or the end of the study period.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetic foot ulcer', 'photobiomodulation', 'low level laser therapy'], 'conditions': ['Diabete Type 2', 'Diabetic Foot Ulcer', 'Photobiomodulation', 'Low Level Laser Therapy']}, 'descriptionModule': {'briefSummary': 'Diabetic foot ulcers (DFU) are among the late complications of DFU, defined as skin lesions that involve the dermis to deeper structures, such as muscles and bones. Although preclinical studies have demonstrated the effects of GaAs 830 nm in diabetic wounds, no clinical studies have been performed, revealing the need for more in-depth analyses to identify the effects and ideal parameterization of PBM with GaAs 830 nm wavelength in the treatment of diabetic ulcers, improving quality of life, as well as to understand the therapeutic feasibility, time required for healing and recurrence rates of these lesions. Experimental, randomized, controlled, double-blind study, with blinding applied to the evaluator and participants. A total of 136 volunteers will be recruited for the research, carried out at the Integrated Center of Medical Specialties (CIEM) - Polyclinic. LLLT GaAs 830nm will be used with three dosages of low, medium and high intensity (4 J/cm², 8 J/cm², 12 J/cm²). The study will have three intervention groups using LLLT with GaAs 830nm and a control group, in which LLLLT will be performed with a GaAs 904nm wavelength and a dose of 10 J/cm², according to Saura et al (2024). This study was approved by the local Research Ethics Committee (Opinion 7,488,044), conducted in accordance with the Declaration of Helsinki and in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteers of both sexes\n* Age over 18 years\n* Medical diagnosis of diabetes mellitus (DM)\n* Presence of diabetic ulcer\n\nExclusion Criteria:\n\n* Autoimmune diseases\n* Infected diabetic ulcers\n* Osteomyelitis\n* Ischemia\n* Concomitant psychiatric disorders\n* Contraindications to treatment methods'}, 'identificationModule': {'nctId': 'NCT07043868', 'briefTitle': 'Effects and Feasibility of Photobiomodulation at 830nm Nanometers in the Treatment of Diabetic Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Piaui'}, 'officialTitle': 'Effects and Feasibility of Photobiomodulation at 830 Nanometers in the Treatment of Diabetic Ulcers: a Randomized, Double-blind Clinical Trial', 'orgStudyIdInfo': {'id': '7.488.044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CG + conventional dressing', 'description': 'The group will receive application of Gallium Arsenide LASER (GasAs) 904nm 10J/cm2 associated with Helianthus annuus oil dressing.', 'interventionNames': ['Device: Low Level Laser Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'GL1 4J/cm2 +conventional dressing', 'description': 'The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 4 J/cm² associated with Helianthus annuus oil dressing.', 'interventionNames': ['Device: Low Level Laser Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'GL2 8J/cm2 +conventional dressing', 'description': 'The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 8J/cm² associated with Helianthus annuus oil dressing.', 'interventionNames': ['Device: Low Level Laser Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'GL1 12J/cm2 +conventional dressing', 'description': 'The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 12J/cm² associated with Helianthus annuus oil dressing.', 'interventionNames': ['Device: Low Level Laser Therapy']}], 'interventions': [{'name': 'Low Level Laser Therapy', 'type': 'DEVICE', 'otherNames': ['Photobiomodulation'], 'description': 'Painless, non-invasive treatment', 'armGroupLabels': ['CG + conventional dressing', 'GL1 12J/cm2 +conventional dressing', 'GL1 4J/cm2 +conventional dressing', 'GL2 8J/cm2 +conventional dressing']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Vinicius Saura Vinicius Saura Cardoso', 'role': 'CONTACT', 'email': 'vscfisio@ufdpar.edu.br', 'phone': '55 86 99984-2919'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Piaui', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vinicius Saura Cardoso', 'investigatorAffiliation': 'Federal University of Piaui'}}}}