Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT01113658
Status:
WITHDRAWN
Last Update Posted:
2022-08-01
First Post:
2010-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the SNaP Wound Care System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}, {'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D014648', 'term': 'Varicose Veins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study was terminated by Spiracur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-29', 'studyFirstSubmitDate': '2010-04-28', 'studyFirstSubmitQcDate': '2010-04-29', 'lastUpdatePostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of complaints about device use and operation', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['negative pressure wound therapy', 'NPWT', 'Spiracur', 'SNaP Wound Care System'], 'conditions': ['Acute and Chronic Wounds', 'Pressure Ulcers', 'Trauma Wounds', 'Diabetic Foot Ulcers', 'Venous Stasis Ulcers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of the FDA-cleared Spiracur SNaP Wound Care System in order to optimize safety, efficacy, and system performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Wound \\< 10 cm in greatest diameter\n* Patient \\>18 years of age\n* Willing and able to sign informed consent\n\nExclusion Criteria:\n\n* Patients with wound-related cellulitis\n* Patients with thick eschar at wound base post debridement\n* Patients with wounds located in an area not amenable to forming an air- tight seal\n* Ulcers due to inflammatory conditions such as pyodermagangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosislipoidicadiabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's syndrome\n* Patient has untreated osteomyelitis\n* Patient is allergic to wound care products\n* Patient wounds with exposed blood vessels not suitable for negative pressure therapy\n* Pregnant or pregnancy-suspected patients\n* Subject actively participating in other clinical trials that conflict with the current study"}, 'identificationModule': {'nctId': 'NCT01113658', 'briefTitle': 'Clinical Evaluation of the SNaP Wound Care System', 'organization': {'class': 'INDUSTRY', 'fullName': '3M'}, 'officialTitle': 'Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System', 'orgStudyIdInfo': {'id': 'SNaP-113009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SNaP', 'description': 'SNaP disposable, mechanically powered Negative Pressure Wound Therapy System', 'interventionNames': ['Device: SNaP Wound Care System']}], 'interventions': [{'name': 'SNaP Wound Care System', 'type': 'DEVICE', 'otherNames': ['Spiracur SNaP Wound Care System', 'SNaP', 'The SNaP System'], 'description': 'The intervention is negative pressure wound therapy (NPWT) with the Spiracur SNaP Wound Care system for the treatment of a variety of acute and chronic wounds including pressure ulcers, trauma wounds, diabetic foot ulcers, venous stasis ulcers, and skin grafts.\n\nThe Spiracur SNaP Wound Care system weighs less than 4 ounces, does not utilize an electric pump (device has no electrically powered parts), is fully disposable after use, and is designed for particularly small chronic wounds that require advanced wound care management. It delivers NPWT at a constant pressure level over several days without any required adjustments by the patient or clinician.', 'armGroupLabels': ['SNaP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94015', 'city': 'Daly City', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Center for Advanced Wound Care', 'geoPoint': {'lat': 37.70577, 'lon': -122.46192}}, {'zip': '94015', 'city': 'Daly City', 'state': 'California', 'country': 'United States', 'facility': 'The SF Center For Advanced Wound Care At', 'geoPoint': {'lat': 37.70577, 'lon': -122.46192}}], 'overallOfficials': [{'name': 'Kristine K Nemes, DPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seton Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '3M', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}