Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-25 @ 1:57 PM
Study NCT ID:
NCT01237392
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
2010-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasonic Wound Debridement vs. Standard Sharp Debridement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-22', 'studyFirstSubmitDate': '2010-11-08', 'studyFirstSubmitQcDate': '2010-11-08', 'lastUpdatePostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to complete wound closure', 'timeFrame': '12 and 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Relative rate of wound healing', 'timeFrame': '8, 12 and 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['wound debridement', 'requiring debridement'], 'conditions': ['Chronic Skin Ulcers']}, 'descriptionModule': {'briefSummary': 'A single center, randomized, parallel, clinical outcome trial to compare the rate of healing in chronic wounds debrided with either high energy ultrasonic debridement (with cavitation) or standard of care sharp debridement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic wound needing debridement \\>3 cm2\n* Ulcer history \\>4mo\n* Adequate arterial blood flow (ABI\\>0.7)\n* Venous, Inflammatory, Pressure, Diabetic\n\nExclusion Criteria:\n\n* Bleeding disorder\n* ABI\\<0.7\n* Uncontrolled diabetes\n* Taking systemic corticosteroids\n* Chemotherapy\n* Participating in another study\n* Treatment with Apligraft, Dermagraft, or Regranex within 90 days'}, 'identificationModule': {'nctId': 'NCT01237392', 'briefTitle': 'Ultrasonic Wound Debridement vs. Standard Sharp Debridement', 'organization': {'class': 'OTHER', 'fullName': 'Calvary Hospital, Bronx, NY'}, 'officialTitle': 'Ultrasonic Surgical Wound Debridement vs. Standard Sharp Debridement In the Treatment of Chronic Wounds: A Single Center, Randomized, Parallel, Clinical Outcome Trial', 'orgStudyIdInfo': {'id': 'NYSDH-Dbr-06-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Contact Ultrasonic Debridement Device', 'interventionNames': ['Device: Contact ultrasonic debridement device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Sharp Debridement', 'interventionNames': ['Device: Contact ultrasonic debridement device']}], 'interventions': [{'name': 'Contact ultrasonic debridement device', 'type': 'DEVICE', 'otherNames': ['SonicOne, Misonix Inc, Farmingdale NY'], 'description': 'Cavitational ultrasound wound debridement device', 'armGroupLabels': ['Contact Ultrasonic Debridement Device', 'Standard Sharp Debridement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Calvary Hospital Center for Curative and Palliative Wound Care', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Oscar M Alvarez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director, Wound care Center, Calvary Hospital'}, {'name': 'Martin E Wendelken, DPM, RN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Physician, Wound Care Center, Calvary Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Calvary Hospital, Bronx, NY', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Center for Curative and Palliative Wound Care', 'investigatorFullName': 'Oscar M. Alvarez, PhD', 'investigatorAffiliation': 'Calvary Hospital, Bronx, NY'}}}}