Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-26 @ 3:30 AM
Study NCT ID:
NCT00563433
Status:
COMPLETED
Last Update Posted:
2020-09-03
First Post:
2007-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D014456', 'term': 'Ulcer'}], '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': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'C093828', 'term': 'pexiganan'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 342}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '1996-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2007-11-21', 'studyFirstSubmitQcDate': '2007-11-21', 'lastUpdatePostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1996-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in clinical signs and symptoms of infection', 'timeFrame': 'Study day 10', 'description': 'Measure will be a comparison of the reduction in clinical signs and symptoms of infection between MSI-78 topical therapy and conventional oral antibiotic therapy'}], 'secondaryOutcomes': [{'measure': 'Microbiological response', 'timeFrame': 'Study day 10', 'description': 'Measure microbiological response to therapy'}, {'measure': 'Wound infection score', 'timeFrame': 'Study day 10', 'description': 'Measure wound infection score'}, {'measure': 'Total wound score', 'timeFrame': 'Study day 10', 'description': 'Measure total wound score'}, {'measure': 'Wound area', 'timeFrame': 'Study day 10', 'description': 'Measure wound area.'}, {'measure': 'Wound depth.', 'timeFrame': 'Study day 10', 'description': 'Measure wound depth.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetic', 'diabetes mellitus', 'foot', 'ulcers', 'Floxin', 'oral antibiotic', 'topical cream'], 'conditions': ['Diabetic Foot Ulcers']}, 'referencesModule': {'references': [{'pmid': '18990064', 'type': 'DERIVED', 'citation': 'Lipsky BA, Holroyd KJ, Zasloff M. Topical versus systemic antimicrobial therapy for treating mildly infected diabetic foot ulcers: a randomized, controlled, double-blinded, multicenter trial of pexiganan cream. Clin Infect Dis. 2008 Dec 15;47(12):1537-45. doi: 10.1086/593185.'}]}, 'descriptionModule': {'briefSummary': '224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.', 'detailedDescription': 'Approximately 224 adults will be enrolled in an outpatient Phase III study to compare the safety and efficacy of topically applied magainin peptide (MSI-78) to that of ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic, in the treatment of infected diabetic foot ulcers.\n\nThis is a randomized, controlled, double-blind trial that will involve twenty or more clinical centers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-hospitalized ambulatory patients with diabetes mellitus\n* Men or Women greater than 18 years old\n* Patients must be considered reliable, willing and able to give consent\n* Female patients must be postmenopausal for a least 6 months or surgically sterilized\n* Localized infection of the ulcer that would ordinarily be treated on an outpatient basis\n* Patients who have been previously treated or are currently under treatment for a localized infections of an ulcer may be enrolled in there has been an adequate response to treatment and ulcer is still infected\n* Patient must have radiograph within two weeks of entry showing no evidence of cortical destruction consistent with osteomyelitis\n* Patient must have a palpable dorsalis pedis or posterior tibial pulse in the affected foot\n* Patient may not be taking or have received any other investigational therapy or approved therapy within 30 days prior to entry\n\nExclusion Criteria:\n\n* Patients requiring concurrent local or systemic antimicrobials during the study period for other infections\n* Patients who are currently treated or awaiting dialysis\n* Patients who are unable to care for their ulcers\n* Patients with known alcohol or substance abuse within 6 months or study entry\n* Patients with significant GI problems or surgery that might interfere with the absorption of ofloxacin\n* Patients who are currently receiving systemic corticosteroids, immunosuppressives, antivirals, radiation therapy or cytotoxic agents\n* Patients who currently require treatment or a primary or metastatic malignancy or have systemically immunocompromising disease.\n* Previous enrollment in this study or previous treatment with MSI-78 Topical Cream\n* Patients with gangrene or severely impaired arterial supply to any portion of the affected foot\n* Other conditions considered by the investigator to be sound reason for disqualification\n* Patients with any known allergy to ofloxacin, other quinolone antibiotics, magainin peptides or ingredients of the vehicle cream\n* Women who are breast feeding, pregnant or attempting to become pregnant'}, 'identificationModule': {'nctId': 'NCT00563433', 'briefTitle': 'MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abeona Therapeutics, Inc'}, 'officialTitle': 'MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers', 'orgStudyIdInfo': {'id': 'MSI-78-304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ofloxacin', 'description': 'an oral antibiotic (ofloxacin 400 mg) twice a day and a placebo vehicle topical cream twice a day for 14 days, extended up to 28 days if clinically warranted', 'interventionNames': ['Drug: ofloxacin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MSI-78', 'description': 'an oral placebo twice a day and MSI-78 1%/2% Topical Cream twice a day for 14 days, extended up to 28 days if clinically warranted.', 'interventionNames': ['Drug: MSI-78']}], 'interventions': [{'name': 'ofloxacin', 'type': 'DRUG', 'otherNames': ['Floxin'], 'description': '400 mg twice a day for 14 days', 'armGroupLabels': ['ofloxacin']}, {'name': 'MSI-78', 'type': 'DRUG', 'description': '1%/2% topical cream twice a day for 14 days', 'armGroupLabels': ['MSI-78']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98108-1597', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle VA Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Paul Litka, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Magainin Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abeona Therapeutics, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Genaera Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}