Online Wound Electronic Medical Record (OWEMR) to Decrease Amputations in Diabetics
OWEMR
Wound EMR to Decrease Limb Amputations in Persons With Diabetes
1 other identifier
interventional
1,609
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2011
Typical duration for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2011
CompletedFirst Posted
Study publicly available on registry
June 10, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedDecember 31, 2014
December 1, 2014
3.2 years
June 9, 2011
December 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lower extremity amputation secondary to diabetic foot ulcer
6 months
Study Arms (2)
OWEMR
EXPERIMENTALMedical centers will be randomized to use the Online Wound Electronic Medical Record to enhance care of patients with diabetic foot ulcers
Standard of Care
NO INTERVENTIONMedical/wound centers will be randomized to continue routine care of patients with diabetic foot ulcers
Interventions
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
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (13)
Phoenix VA Hospital
Phoenix, Arizona, 85012, United States
University of Arizona
Tuscon, Arizona, 85719, United States
Western University Health Sciences
Pomona, California, 91766, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
Aiyan Diabetes Center
Evans, Georgia, 30809, United States
Elks Wound Center
Meridian, Idaho, 83642, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
North Shore Long Island Jewish Health System
Lake Success, New York, 10042, United States
Bellevue Hospital
New York, New York, 10016, United States
Metropolitan Hospital
New York, New York, 10029, United States
Lincoln Hospital
New York, New York, 10451, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen M Warren, MD
NYU School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 9, 2011
First Posted
June 10, 2011
Study Start
July 1, 2011
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
December 31, 2014
Record last verified: 2014-12