Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-26 @ 4:14 AM
Study NCT ID:
NCT01351493
Status:
UNKNOWN
Last Update Posted:
2012-07-11
First Post:
2011-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Pressure Sore
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009569', 'term': 'Nitric Oxide'}], 'ancestors': [{'id': 'D026361', 'term': 'Reactive Nitrogen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-10', 'studyFirstSubmitDate': '2011-05-09', 'studyFirstSubmitQcDate': '2011-05-10', 'lastUpdatePostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure ulcer stage assessment after the endpoint of intervention period', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'The secondary efficacy end point will be pressure sore scale assessment of improvement.', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pressure sore', 'nitric oxide'], 'conditions': ['Pressure Ulcer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of nitric oxide gel for pressure sore recovery.', 'detailedDescription': 'Pressure sore is a common problem for patient with bed-ridden. The care of pressure sore cost many social and medical resource, and also effect the quality of life of patients. Current principles of treatment of pressure sore include adequate pain control, optimizing nutritional status, pressure relief, wound cleaning and dressing, infection control and surgical intervention if needed. Wound dressings should be based on wound characteristics. However, for improving wound healing, different dressing materials were developed.\n\nThere are increased evidences implicate nitric oxide (NO) synthesis plays an important role in the process of wound healing. Nitric oxide involve in angiogenesis, mediating inflammatory process, cell proliferation and collagen disposition, then improving wound healing. One study used topic NO-gel to mice with second degree burn wound, and found that the NO gel had the potential to enhance burn wound healing by regulation of many cellular processes in the skin. Based on the findings, the investigators hypothesize that NO gel could be used as an alternative method for pressure sore dressing to enhance wound healing.\n\nThis is a 12-week study. The investigators plan to enroll 40 subjects. The run-in period is set for screening based on inclusion and exclusion criteria. Baseline data including demographic profiles, medical history and current medications will be obtained, followed by an intact pressure sore inspection. Pressure ulcer stage (developed by NPAUP) , Pressure Ulcer Scale for Healing(PUSH) and Pressure Sore Status Tool(PSST) will be recorded before randomization. Baseline photograph of pressure sore will be taken .\n\nDuring the treatment phase, a NO gel or placebo gel will be administered on the pressure sore wound by caregiver once or twice daily (decided by doctor according to clinical condition) after standard wound cleaning with normal saline. During the treatment period, the study subjects will be followed- up every 2 weeks to record the wound condition and any side effect. The investigators will use stage, PUSH and PSST, and take serial photograph to monitor wound condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who live in nursing home\n* Clinical diagnosis of pressure sore \\> grade II(grade developed by NPAUP)\n* without acute illness required hospitalization\n* able to understanding and signed the Inform Consent Form after detailed description of the treatment and potential risks and benefits\n\nExclusion Criteria:\n\n* diagnosis of cancer and still on active therapies\n* on other medications with pharmacological actions may lead to excessive formation of nitric oxide, or may accentuate drug effects due to excessive formation of nitric oxide\n* with systemic infection and need systemic antibiotics\n* pressure sore local infection and need topic antibiotic(for pressure sore wound)\n* with any known allergic reaction to any ingredient in the 2 gel prescriptions\n* Subjects who have been enrolled into any other clinical study in the preceding 3 months prior to randomization'}, 'identificationModule': {'nctId': 'NCT01351493', 'briefTitle': 'Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Pressure Sore', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Pressure Sore', 'orgStudyIdInfo': {'id': 'DMR100-IRB-030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nitric oxide gel', 'interventionNames': ['Drug: Nitric Oxide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Nitric Oxide', 'type': 'DRUG', 'description': 'Nitric Oxide Gel, once or twice per day, 12weeks', 'armGroupLabels': ['Nitric oxide gel']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo Gel, once or twice per day, 12weeks', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '404', 'city': 'Taichung', 'state': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chih-Hsueh Lin, MD.Msc.', 'role': 'CONTACT', 'email': 'd5496@mail.cmuh.org.tw', 'phone': '886-4-22052121', 'phoneExt': '4507'}, {'name': 'Chih-Hsueh Lin, MD.MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Chiu-Shong Liu, MD.MSc.', 'role': 'CONTACT', 'email': 'liucs@ms14.hinet.net', 'phone': '886-975681842'}], 'overallOfficials': [{'name': 'Chiu-Shong Liu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}