Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-11 @ 1:03 AM
Study NCT ID:
NCT03627702
Status:
COMPLETED
Last Update Posted:
2018-08-13
First Post:
2018-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Bedsores With VIP Light
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2018-05-26', 'studyFirstSubmitQcDate': '2018-08-09', 'lastUpdatePostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'scale Dutch Consensus Prevention of Bedsores CBO', 'timeFrame': 'The first day of the therapy (one measure)', 'description': 'Scale Dutch Consensus Prevention of Bedsores CBO - score on a scale of 0 to 3 points of mental state, neurological status, ability to move, nutritional status, way of eating, function of the anal sphincters and urethra, age, body temperature, medicines, comorbid diabetes. 8 points or more indicate a risk of bedsores.'}, {'measure': 'Bedsores classification: the Torrance system', 'timeFrame': 'Change is being assessed after 36 days', 'description': 'Assessment of the degree damage and color of tissue.\n\n1°-the lowest degree of bedsore 5°- the highest degree of bedsore'}, {'measure': 'Measurement of bedsores size', 'timeFrame': 'Change is being assessed after 36 days', 'description': 'Vertical and horizontal size of bedsores'}], 'secondaryOutcomes': [{'measure': 'Photo of bedsores', 'timeFrame': 'On the first, 9, 18 and 36 day of therapy', 'description': 'Visual image of bedsores'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Light; Therapy; Bedsore']}, 'referencesModule': {'references': [{'pmid': '25991879', 'type': 'BACKGROUND', 'citation': 'Bhattacharya S, Mishra RK. Pressure ulcers: Current understanding and newer modalities of treatment. Indian J Plast Surg. 2015 Jan-Apr;48(1):4-16. doi: 10.4103/0970-0358.155260.'}, {'pmid': '26677269', 'type': 'RESULT', 'citation': 'Thomas E, Vinodkumar S, Mathew S, Setia MS. A Study of the Factors Associated with Risk for Development of Pressure Ulcers: A Longitudinal Analysis. Indian J Dermatol. 2015 Nov-Dec;60(6):566-72. doi: 10.4103/0019-5154.169127.'}, {'pmid': '29188066', 'type': 'RESULT', 'citation': 'Rutteman B, Borremans K, Beckers J, Devleeschouwer E, Lampmann S, Corthouts I, Verlinde P. Aeromonas wound infection in a healthy boy, and wound healing with polarized light. JMM Case Rep. 2017 Oct 16;4(10):e005118. doi: 10.1099/jmmcr.0.005118. eCollection 2017 Oct.'}, {'pmid': '21631376', 'type': 'RESULT', 'citation': 'Oliveira PC, Pinheiro AL, de Castro IC, Reis JA Jr, Noia MP, Gurgel C, Teixeira Cangussu MC, Pedreira Ramalho LM. Evaluation of the effects of polarized light (lambda400-200 nm) on the healing of third-degree burns in induced diabetic and nondiabetic rats. Photomed Laser Surg. 2011 Sep;29(9):619-25. doi: 10.1089/pho.2010.2914. Epub 2011 Jun 1.'}, {'pmid': '17069493', 'type': 'RESULT', 'citation': 'Pinheiro AL, Meireles GC, Carvalho CM, de Barros Vieira AL, dos Santos JN, Ramalho LM. Biomodulative effects of polarized light on the healing of cutaneous wounds on nourished and undernourished Wistar rats. Photomed Laser Surg. 2006 Oct;24(5):616-24. doi: 10.1089/pho.2006.24.616.'}, {'pmid': '19156105', 'type': 'RESULT', 'citation': "Ishmamet'ev II, Deriabin EI, Zharov VV, Ishmamet'ev IL, Tochilova ER. [Microcirculation changes after polarized polychromatic light use in preoperative period in cases of face cosmetic operations]. Stomatologiia (Mosk). 2008;87(6):38-40. Russian."}, {'pmid': '29192340', 'type': 'RESULT', 'citation': 'Akilbekova D, Boddupalli A, Bratlie KM. The effect of polarized light on the organization of collagen secreted by fibroblasts. Lasers Med Sci. 2018 Apr;33(3):539-547. doi: 10.1007/s10103-017-2398-0. Epub 2017 Nov 30.'}, {'pmid': '19680158', 'type': 'RESULT', 'citation': 'Tada K, Ikeda K, Tomita K. Effect of polarized light emitting diode irradiation on wound healing. J Trauma. 2009 Nov;67(5):1073-9. doi: 10.1097/TA.0b013e318187ad02.'}], 'seeAlsoLinks': [{'url': 'http://evereth.pl/odlezyny-fizjoterapia-w-procesie-leczenia/', 'label': 'Pressure ulcers - physiotherapy in the treatment process'}]}, 'descriptionModule': {'briefSummary': 'Difficulty healing wounds have a significant effect to the general fitness of the patient and his quality of life. On Account of the frequency of their appearing, constitute the serious health and social problem. In comprehensive dealing with such patients physiotherapy will matter greatly. The visible polychromatic polarized light is most often used physical factor assisting comprehensive treatment bedsores.\n\nPurpose of the work: Analyze of using the visible polychromatic polarized light in the comprehensive process of healing bedsores at elderly people with the limited motor activity.\n\nMaterial and methods: Participants receive interventions as part of routine medical care, and a researcher studies the effect of the intervention. The study was conducted in people over 65 years old, with bedsores grade III and IV in Torrance scale. The therapy included radiation of bedsores with VIP light. Effectiveness of the method of treatment was examined using photographic images and to measure the extent of the wound.', 'detailedDescription': '18 people were examined. In all subjects, were assessed the risk of developing bedsores according to the scale Dutch Consensus Prevention of Bedsores CBO. All bedsores were irradiated with a Bioptron lamp (20 sessions, twice a day). Photo and measurement of bedsores size and Torrance score, were made:on the first, 9, 18 and 36 day of therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'nursing home residents', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a high risk of bedsores development (Dutch Consensus Prevention of Bedsores CBO)\n* having a bedsore(s)\n* permanent stay in a nursing home\n* recommended light therapy (VIP light)\n\nExclusion Criteria:\n\n* ability to locomotion\n* age under 65 years old'}, 'identificationModule': {'nctId': 'NCT03627702', 'briefTitle': 'Treatment of Bedsores With VIP Light', 'organization': {'class': 'OTHER', 'fullName': 'University of Rzeszow'}, 'officialTitle': 'The Effect of VIP Light on Healing Bedsores Process', 'orgStudyIdInfo': {'id': 'Piler'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'All bedsores were irradiated with a Bioptron lamp. Photo and measurement of bedsores size and Torrance score, were made: on the first, 9,18 and 36 day of therapy.', 'interventionNames': ['Radiation: Irradiated VIP (Visible Incoherent Polarized)']}], 'interventions': [{'name': 'Irradiated VIP (Visible Incoherent Polarized)', 'type': 'RADIATION', 'description': '20 irradiations were performed twice a day. The exposure time was 10 minutes. Exposure was made at a distance of 10 cm.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jolanta Zwolińska, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rzeszow'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Lack of consent of participants due to difficult contact'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rzeszow', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Jolanta Zwolińska', 'investigatorAffiliation': 'University of Rzeszow'}}}}