Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-02-21 @ 3:09 PM
Study NCT ID:
NCT04689620
Status:
UNKNOWN
Last Update Posted:
2020-12-30
First Post:
2020-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Helium Neon Laser Versus Gallium Arsenide Laser
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-12-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-27', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2020-12-27', 'lastUpdatePostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wound surface area', 'timeFrame': 'two months', 'description': 'measuring the ulcer surface area by smart phone application'}, {'measure': 'number of bacteria in wound', 'timeFrame': 'two months', 'description': 'measuring number of bacteria by colony count'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Venous Leg Ulcer']}, 'descriptionModule': {'briefSummary': 'There will be different effects for different laser wavelengths in treatment of venous ulcer.', 'detailedDescription': "The cost of treating venous ulcer can vary within wide limits and depends on the technology used. In the countries of the European community, the closure of one ulcer as an outpatient procedure costs 800-1500 euros, and supporting anti-relapse treatment makes 100-150 euros per month. In the United States, for closure of venous ulcer within 3 months, direct medical costs reach US$1500- 2000. Prolongation of the treatment for a longer time results in increased cost up to US$30 000 or more.\n\nPoor efficiency of the known methods of treating patients with venous ulcer necessitates the search for new ways and modes of laser therapy (LT) based on a comprehensive approach. Application of physical therapy, primarily with the use of LLLT, capable of influencing various stages in the pathogenesis of the disease, allows a high therapeutic effect in many cases, while ensuring systemic response of the patient's body with the proper exposure procedure.\n\nSo, the current study will be conducted to compare the effect of different laser wavelengths on venous ulcers and provide an effective treatment method for patients with venous ulcers with low cost and in short duration."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients approximately the same age (50-60).\n* All patients had venous leg ulcers just above medial malleolus. The common cause of ulcers for all cases was venous insufficiency.\n* All patients with conscious.\n\nExclusion Criteria:\n\n* All patients had no diabetes or blood problems.\n* any immunity disorder affect wound heaing.'}, 'identificationModule': {'nctId': 'NCT04689620', 'briefTitle': 'Helium Neon Laser Versus Gallium Arsenide Laser', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Helium Neon Laser Versus Gallium Arsenide Laser In Healing Of Venous Ulcers', 'orgStudyIdInfo': {'id': 'Beni Suef University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HELIUM NEON LASER plus regular ulcer care', 'description': 'laser scanning the wound with 9.6 jole/cm2 then regular dressing', 'interventionNames': ['Device: laser']}, {'type': 'EXPERIMENTAL', 'label': 'GALLIUM ARSENIDE plus regular ulcer care', 'description': 'laser scanning the wound with 9.6 jole/cm2 then regular dressing', 'interventionNames': ['Device: laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'regular ulcer care', 'description': 'dressing for the ulcer', 'interventionNames': ['Device: laser']}], 'interventions': [{'name': 'laser', 'type': 'DEVICE', 'description': 'treating the venous ulcer with laser', 'armGroupLabels': ['GALLIUM ARSENIDE plus regular ulcer care', 'HELIUM NEON LASER plus regular ulcer care', 'regular ulcer care']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'statistical analysis plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahmoud Awad Ramadan Elkholy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mahmoud Awad Ramadan Elkholy', 'investigatorAffiliation': 'Beni-Suef University'}}}}