Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT01371318
Status:
COMPLETED
Last Update Posted:
2014-12-31
First Post:
2011-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Online Wound Electronic Medical Record (OWEMR) to Decrease Amputations in Diabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D016523', 'term': 'Foot Ulcer'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D005534', 'term': 'Foot Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1609}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-29', 'studyFirstSubmitDate': '2011-06-09', 'studyFirstSubmitQcDate': '2011-06-09', 'lastUpdatePostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower extremity amputation secondary to diabetic foot ulcer', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetic foot ulcer', 'amputation', 'wounds', 'diabetic foot', 'diabetes complications'], 'conditions': ['Wounds', 'Diabetes Complications', 'Diabetic Foot', 'Foot Ulcer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether using the OWEMR as part of the standard of care for Diabetic Foot Ulcers reduces the rate of lower limb amputations and to quantify the relationship between glycemic control and the rate of amputation secondary to chronic foot ulcers in Type II Diabetes.', 'detailedDescription': 'The Online Wound Electronic Medical Record (OWEMR) is a medical informatics tool that synthesizes data about complex wound problems from multiple sources and is innovative in its capability to performing these critical tasks: i) identification of the information needed to make treatment decisions at the point of care in real time ii) use intelligent search and report features to identify patients who require emergency interventions, and iii) provide evidence-based clinical decision support to clinicians. Use of the OWEMR includes digital photography as an objective measurement of wound healing rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Signed informed Consent\n* Type I or II diabetes\\*\n* A break in the skin on the foot ≥ 0.5cm2\n* 18 yrs of age or older\n* Hemoglobin A1c value within the last 120 days\n* No use of Investigational Agents /Devices on study or within 30 days prior to enrollment\n* Subjects who will be locally available for the next 6 months'}, 'identificationModule': {'nctId': 'NCT01371318', 'acronym': 'OWEMR', 'briefTitle': 'Online Wound Electronic Medical Record (OWEMR) to Decrease Amputations in Diabetics', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Wound EMR to Decrease Limb Amputations in Persons With Diabetes', 'orgStudyIdInfo': {'id': 'R01HS019218-01', 'link': 'https://reporter.nih.gov/quickSearch/R01HS019218-01', 'type': 'AHRQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OWEMR', 'description': 'Medical centers will be randomized to use the Online Wound Electronic Medical Record to enhance care of patients with diabetic foot ulcers', 'interventionNames': ['Other: Online Wound Electronic Medical Record']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Medical/wound centers will be randomized to continue routine care of patients with diabetic foot ulcers'}], 'interventions': [{'name': 'Online Wound Electronic Medical Record', 'type': 'OTHER', 'description': 'Online Wound Electronic Medical Record is a medical informatics tool that synthesizes data about complex wound problems from multiple sources and is innovative in its capability to performing these critical tasks: i) identification of the information needed to make treatment decisions at the point of care in real time ii) use intelligent search and report features to identify patients who require emergency interventions, and iii) provide evidence-based clinical decision support to clinicians', 'armGroupLabels': ['OWEMR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix VA Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85719', 'city': 'Tuscon', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona'}, {'zip': '91766', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Western University Health Sciences', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Healthcare System', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '30809', 'city': 'Evans', 'state': 'Georgia', 'country': 'United States', 'facility': 'Aiyan Diabetes Center', 'geoPoint': {'lat': 33.53375, 'lon': -82.13067}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Elks Wound Center', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore Long Island Jewish Health System', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Bellevue Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Metropolitan Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10451', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Lincoln Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Stephen M Warren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stephen Warren', 'investigatorAffiliation': 'NYU Langone Health'}}}}