Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-05 @ 6:31 PM
Study NCT ID:
NCT03204851
Status:
UNKNOWN
Last Update Posted:
2020-02-25
First Post:
2017-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microlyte Dressing in the Management of Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2017-06-28', 'studyFirstSubmitQcDate': '2017-06-28', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure.', 'timeFrame': '90 days', 'description': 'Wound Healing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Wound Heal']}, 'descriptionModule': {'briefSummary': "The purpose of this pilot study is to assess the efficacy of Microlyte Ag wound dressing when used in complex skin wounds. Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans. Primary clinical end point of study is percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure. Patient population comprises patients referred to Mission's Wound Healing and Hyperbaric Center for management of their wounds. Targeted enrollment is 100 subjects distributed into 4 study cohorts corresponding to the type of wound treated: venous stasis ulcer (20 patients); diabetic foot ulcer \\[DFU\\] (20 patients); pressure ulcer (20 patients); wounds of various other etiologies (40 patients)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women ≥18 years of age, inclusive\n* Venous stasis ulcer, DFU, pressure ulcer, or other wound sufficiently complex as to be referred to Clinical Investigators at Mission's Wound Care and Bariatric Center\n* Patient must be competent to consent for self\n\nExclusion Criteria:\n\n* Patients younger than 18 years of age\n* Women who are pregnant or nursing\n* Prisoners"}, 'identificationModule': {'nctId': 'NCT03204851', 'acronym': 'Microlyte', 'briefTitle': 'Microlyte Dressing in the Management of Wounds', 'organization': {'class': 'OTHER', 'fullName': 'Mission Health System, Asheville, NC'}, 'officialTitle': 'An Open-Label Prospective Pilot Study to Evaluate the Efficacy and Tolerability of Microlyte Ag Pre-Dressing in the Management of Complex Skin Wounds.', 'orgStudyIdInfo': {'id': '16-08-1608'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Venous Stasis Ulcer', 'description': 'Venous Stasis Ulcer', 'interventionNames': ['Device: Wound Healing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pressure Ulcers', 'description': 'Pressure Ulcers', 'interventionNames': ['Device: Wound Healing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diabetic Foot Ulcers', 'description': 'Diabetic Foot Ulcers', 'interventionNames': ['Device: Wound Healing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wounds from a variety of etiologies', 'description': 'Wounds from a variety of etiologies', 'interventionNames': ['Device: Wound Healing']}], 'interventions': [{'name': 'Wound Healing', 'type': 'DEVICE', 'description': 'Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans with skin wounds.', 'armGroupLabels': ['Diabetic Foot Ulcers', 'Pressure Ulcers', 'Venous Stasis Ulcer', 'Wounds from a variety of etiologies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Boone, BS', 'role': 'CONTACT', 'email': 'ashley.boone@msj.org', 'phone': '828-213-3961'}, {'name': 'Nicole Gunn, MA', 'role': 'CONTACT', 'email': 'nicole.gunn@msj.org', 'phone': '828-213-7055'}], 'facility': 'Mission Health System', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}], 'centralContacts': [{'name': 'Lorinda Baker', 'role': 'CONTACT', 'email': 'lorinda.baker@hcahealthcare.com', 'phone': '828-257-4744'}, {'name': 'Ashley Boone, BS', 'role': 'CONTACT', 'email': 'Ashley.boone@hcahealthcare.com', 'phone': '828-213-3961'}], 'overallOfficials': [{'name': 'William Shillinglaw, DO', 'role': 'STUDY_CHAIR', 'affiliation': 'Mission Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mission Health System, Asheville, NC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imbed Biosciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}