Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-31 @ 2:39 PM
Study NCT ID:
NCT01493895
Status:
UNKNOWN
Last Update Posted:
2013-03-22
First Post:
2011-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Assessing Safety and Efficacy of B-cure Laser Treating Diabetic Chronic Wounds
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'lastUpdateSubmitDate': '2013-03-21', 'studyFirstSubmitDate': '2011-12-15', 'studyFirstSubmitQcDate': '2011-12-15', 'lastUpdatePostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the efficacy of b-cure laser in patients with diabetes mellitus induced lower leg skin ulcers', 'description': 'the efficacy will be assesed using measurement of wound depth.'}], 'secondaryOutcomes': [{'measure': 'safety', 'description': 'safety will be evaluated by counting advese events in each group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Foot Ulcer']}, 'referencesModule': {'references': [{'pmid': '34052927', 'type': 'DERIVED', 'citation': 'Haze A, Gavish L, Elishoov O, Shorka D, Tsohar T, Gellman YN, Liebergall M. Treatment of diabetic foot ulcers in a frail population with severe co-morbidities using at-home photobiomodulation laser therapy: a double-blind, randomized, sham-controlled pilot clinical study. Lasers Med Sci. 2022 Mar;37(2):919-928. doi: 10.1007/s10103-021-03335-9. Epub 2021 May 29.'}]}, 'descriptionModule': {'briefSummary': 'For centuries, light has been a well-known and effective healing method. In the beginning of the 20th century there was a first attempt to condense light energy and distribute it in higher levels, a use that was successfully applied on many soldiers wounded in the Second World War. The laser, which is based on the quantum phenomenon of stimulated emission, was first demonstrated in the beginning of the 1960s and immediately received many applications in all areas of medicine.Many different studies were carried out in the past decade trying to assess the effect of laser therapy on properties of healing wounds. This study aim to assess the efficacy and safety of Low-Level Laser Therapy (LLLT) in the treatment of non-healing diabetic foot ulcers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Known Diabetes mellitus\n2. With an active chronic wound in the foot, that has been treated conventionally for over 3 months.\n3. No known osteomyelitis.\n4. Size of wound: 1-8 cm2.\n5. Ages: 21 - 75\n6. Gender: male and female\n\nExclusion Criteria:\n\n1. Signs of osteomyelitis.\n2. The ability to probe to bone with the presence of local or systemic infection and suggestive radiological features provided a clinical diagnosis of osteomyelitis.\n3. There is active osteomyelitis in the bone underlying the ulcer.\n4. Pregnant women.\n5. Children under 21.\n6. Presence of or known cancerous comorbidity.'}, 'identificationModule': {'nctId': 'NCT01493895', 'briefTitle': 'Study Assessing Safety and Efficacy of B-cure Laser Treating Diabetic Chronic Wounds', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'orgStudyIdInfo': {'id': 'becure-CTIL-HMO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group,', 'description': 'The control group will be treated with a sham B-cure laser machine, emitting only green indicator light and no 808nm laser.', 'interventionNames': ['Device: standard hoem treatment']}, {'type': 'EXPERIMENTAL', 'label': 'study, LLLT-808 B-cure laser machine', 'description': 'The study group will be treated with the LLLT-808 B-cure laser machine, emitting the 808nm laser beam together with a green indicator light.', 'interventionNames': ['Device: LLLT-808 B-cure laser machine']}], 'interventions': [{'name': 'standard hoem treatment', 'type': 'DEVICE', 'description': 'All treatments will be carried out by trained study caregivers that will give standard treatment to all the participants under their care.\n\nEvery treatment will consist of the following steps:\n\nA thorough rinse with an antiseptic soap (Septal scrub) with a stream of warm water.\n\nDrying of the foot with an absorbable disposable paper towel. Using clean latex gloves the caregiver will beam the ulcer with LLLT 808, B-cure laser machine in the following method.', 'armGroupLabels': ['control group,']}, {'name': 'LLLT-808 B-cure laser machine', 'type': 'DEVICE', 'description': 'From the day of entering the study, ulcers will be treated twice daily regardless of the treatment that was used until then.\n\nAll treatments will be carried out by trained study caregivers that will give standard treatment to all the participants under their care.\n\nEvery treatment will consist of the following steps:\n\nA thorough rinse with an antiseptic soap (Septal scrub) with a stream of warm water.\n\nDrying of the foot with an absorbable disposable paper towel. Using clean latex gloves the caregiver will beam the ulcer with LLLT 808, B-cure laser machine in the following method.\n\nThe part of the laser machine from which the laser beam is radiating - the beam guard, will be cleaned with a disposable swab of 70% alcohol. The cleaning will be performed while the machine is pointing downwards.', 'armGroupLabels': ['study, LLLT-808 B-cure laser machine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Meir Liebergall, Prof.', 'role': 'CONTACT', 'phone': '972-2-6776342'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}