Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-02 @ 4:07 AM
Study NCT ID:
NCT04018469
Status:
WITHDRAWN
Last Update Posted:
2022-04-19
First Post:
2019-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patterned Electric Dressing Effects on Open Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'wound debrided tissue and tissue biopsy sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '3 Weeks', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'not enough staff to execute study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-12', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-07-11', 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial colonization & culture', 'timeFrame': '3 weeks or until amputation, whichever comes first', 'description': 'Bacteria colonization (cultures results high, moderate, low or negative).'}, {'measure': 'Necrotic tissue assessed through light microscopy of tissue biopsies', 'timeFrame': '3 weeks or until amputation, whichever comes first', 'description': 'Hematoxylin and Eosin staining of tissue sections to measure extent of tissue necrosis at baseline and compared to tissue obtained at surgery after PED treatment.% necrotic tissue will be measured.'}], 'secondaryOutcomes': [{'measure': 'Wound area measured before and after wound treatment', 'timeFrame': '3 weeks or until amputation, whichever comes first', 'description': 'To determine the effect of PED on % wound closure based on wound measurements at baseline and end of PED treatment.'}, {'measure': 'Bacterial biofilm through Scanning Electron Microscopy analysis', 'timeFrame': '3 weeks or until amputation, whichever comes first', 'description': 'Perform scanning electron microscopy to detect bacterial biofilm (high, moderate, low or negative) before and after PED treatment.'}, {'measure': 'Bacterial contamination assessed through Colony Forming Units', 'timeFrame': '3 weeks or until amputation, whichever comes first', 'description': 'Colony forming units will be measured from tissue samples and dressings to quantitate bacterial contamination levels at baseline and after PED treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PED Wound Dressing'], 'conditions': ['Amputation', 'Open Wound']}, 'referencesModule': {'references': [{'pmid': '21457463', 'type': 'BACKGROUND', 'citation': 'Ammons MC, Ward LS, James GA. Anti-biofilm efficacy of a lactoferrin/xylitol wound hydrogel used in combination with silver wound dressings. Int Wound J. 2011 Jun;8(3):268-73. doi: 10.1111/j.1742-481X.2011.00781.x. Epub 2011 Apr 1.'}, {'pmid': '10334980', 'type': 'BACKGROUND', 'citation': 'Costerton JW, Stewart PS, Greenberg EP. Bacterial biofilms: a common cause of persistent infections. Science. 1999 May 21;284(5418):1318-22. doi: 10.1126/science.284.5418.1318.'}, {'pmid': '12825991', 'type': 'BACKGROUND', 'citation': 'Douglas LJ. Medical importance of biofilms in Candida infections. Rev Iberoam Micol. 2002 Sep;19(3):139-43.'}, {'pmid': '12665817', 'type': 'BACKGROUND', 'citation': 'Schachter B. Slimy business--the biotechnology of biofilms. Nat Biotechnol. 2003 Apr;21(4):361-5. doi: 10.1038/nbt0403-361. No abstract available.'}]}, 'descriptionModule': {'briefSummary': '1. This study is a pilot feasibility study to determine treatment effects to estimate sample size for future studies that evaluate wound bacteria colonization.\n2. The secondary objective of this study aims to observe the effect of PED on an open wound and its effects in wound bacteria colonization.', 'detailedDescription': "This study is designed as a pilot study where 30 patients receiving a below the knee amputation with at least one open wound on the limb will be enrolled. Patients are identified through medical records. The patients will be selected based on inclusion and exclusion criteria through pre-screening through the Comprehensive Wound Center's Limb Preservation Program and wound physicians/providers at Indiana University. The decision of amputation is made independently of the study and is solely made by the patient and their physician/provider. The provider decides based on the severity of the limb's condition if/when the limb should be amputated and will schedule this surgery with the patient based on current clinical standard of care. Study participation is decided independent of clinical decision. Patients enrolled in the study will wear the Patterned Electric Dressing (PED) on the wound(s) for up to 3 weeks or until amputation, whichever comes first and will have up to a total of 4 study visits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "In this study 30 patients receiving a below the knee amputation with at least one open wound on the limb will be enrolled. Patients are identified through medical records. The patients will be selected based on inclusion and exclusion criteria through pre-screening through the Comprehensive Wound Center's Limb Preservation Program and wound physicians/providers at Indiana University. Patients enrolled in the study will wear the Patterned Electric Dressing (PED) on the wound(s) for up to 3 weeks or until amputation, whichever comes first and will have up to a total of 4 study visits.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18 years and older\n* Patients identified to be receiving a non-traumatic below the knee amputation within 3 weeks of enrollment\n* The affected limb to be amputated must have at least one open wound\n\n * Wound(s) must be able to be covered by 3x3 dressing\n* Subjects willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Pregnant women\n* Prisoners\n* Individuals lacking consent capacity'}, 'identificationModule': {'nctId': 'NCT04018469', 'acronym': 'PED', 'briefTitle': 'Patterned Electric Dressing Effects on Open Wounds', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Patterned Electric Dressing Effects on Open Wounds', 'orgStudyIdInfo': {'id': '1807454805'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No Interventions', 'type': 'OTHER', 'description': 'No Interventions'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'IU Health Methodist Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Gordillo Gayle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gayle Gordillo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gayle Gordillo', 'investigatorAffiliation': 'Indiana University'}}}}