Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-01-02 @ 12:13 PM
Study NCT ID:
NCT00234559
Status:
WITHDRAWN
Last Update Posted:
2024-12-02
First Post:
2005-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study terminated due to no subject enrollment.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2005-10-05', 'studyFirstSubmitQcDate': '2005-10-05', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Altered proteomic expression evaluated by angiogenic markers using biomolecular assays of biopsy samples at Day 0, Day 3, Day 7, Day 21, and Day 28'}], 'secondaryOutcomes': [{'measure': 'Increased angiogenesis of the lower extremity wound will be quantified using the MicroScan™ (video microscope) at Day 0, Day 3, Day 7, Day 21, Day 28, Day 42, and at follow up visit.'}]}, 'conditionsModule': {'keywords': ['Angiogenesis', 'Post surgical dehisced wounds of the lower extremity'], 'conditions': ['Wounds']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine:\n\n1. If vacuum assisted closure (VAC®) therapy results in altered proteomic expression of angiogenic markers compared to moist wound therapy.\n2. If VAC® therapy results in increased angiogenesis compared to moist wound therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is male or female and \\> 18 years old.\n* Patient or patient's legal authorized representative is willing to sign informed consent.\n* Patient has a post surgical dehisced wound of the lower extremity for longer than two weeks and less than one month.\n* Patient has transcutaneous oximetry (TcPO2) evaluation that demonstrated tissue hypoxia in the periwound region, as indicated by a reading of 10-40 mmHg within the prior two weeks.\n* Ankle Brachial Index \\> 0.7 within the prior two weeks.\n* Patient is not pregnant (pregnancy test is negative) and non-lactating at Visit 1.\n* Patient does not plan on becoming pregnant during the course of the study.\n* Patient is willing to use effective method of contraception for the duration of the study, is permanently sterilized, or post-menopausal as defined by cessation of menses for at least one year prior to enrollment in study.\n\nExclusion Criteria:\n\n* Diagnosed and untreated wound infection.\n* Poor nutrition status as evidenced by pre-albumin \\< 12mg/dl within the past 30 days or extracellular mass \\< 95%.\n* Presence of sickle cell disease.\n* Presence of connective tissue disease (e.g. history of or active lupus).\n* Hemoglobin A1c (HbA1c) levels greater than 9% thirty days prior to screening visit (if patient is confirmed diabetic).\n* Treatment with an investigational therapy within the previous 30 days.\n* Lower extremity wound (under consideration for study) with malignancy.\n* Lower extremity wound (under consideration for study) with untreatable cellulitis.\n* Presence of untreated osteomyelitis.\n* Presence of any systemic hematologic disorder or condition that would impede healing.\n* History of radiation to the wound area.\n* History of drugs that may delay wound healing.\n* History of thermal injury to the wound area.\n* Prior VAC® therapy to the wound within 30 days of enrollment.\n* Current or prior treatment with hyperbaric oxygen therapy (HBO) or warm-up therapy to the same wound.\n* Recent diagnosis of cancer or active management of cancer within the last year.\n* Treatment with skin or dermal substitutes or dressings with living cells capable of producing growth factors within the previous 30 days.\n* End stage renal disease.\n* History of alcohol or drug abuse that may impact protocol compliance or delay wound healing.\n* Known hypersensitivity to hydrogel or any disposable component of the VAC® Therapy System.\n* Necrotic tissue with eschar present which cannot be debrided.\n* Any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into the study."}, 'identificationModule': {'nctId': 'NCT00234559', 'briefTitle': 'Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solventum US LLC'}, 'officialTitle': 'A Randomized Controlled Study Comparing Vacuum Assisted Closure® Therapy to Moist Wound Therapy in Angiogenesis', 'orgStudyIdInfo': {'id': 'VACP2005-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'VAC® Therapy System', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jeffrey A Niezgoda, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Luke's Medical Center of Aurora Health Care"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KCI USA, Inc', 'class': 'INDUSTRY'}}}}