Online Wound Electronic Medical Record (OWEMR) to Decrease Amputations in Diabetics (OWEMR)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01371318 |
Recruitment Status :
Completed
First Posted : June 10, 2011
Last Update Posted : December 31, 2014
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Condition or disease | Intervention/treatment | Phase |
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Wounds Diabetes Complications Diabetic Foot Foot Ulcer | Other: Online Wound Electronic Medical Record | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1609 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Wound EMR to Decrease Limb Amputations in Persons With Diabetes |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: OWEMR
Medical centers will be randomized to use the Online Wound Electronic Medical Record to enhance care of patients with diabetic foot ulcers
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Other: Online Wound Electronic Medical Record
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 |
No Intervention: Standard of Care
Medical/wound centers will be randomized to continue routine care of patients with diabetic foot ulcers
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- Lower extremity amputation secondary to diabetic foot ulcer [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- Signed informed Consent
- Type I or II diabetes*
- A break in the skin on the foot ≥ 0.5cm2
- 18 yrs of age or older
- Hemoglobin A1c value within the last 120 days
- No use of Investigational Agents /Devices on study or within 30 days prior to enrollment
- Subjects who will be locally available for the next 6 months

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371318
United States, Arizona | |
Phoenix VA Hospital | |
Phoenix, Arizona, United States, 85012 | |
University of Arizona | |
Tuscon, Arizona, United States, 85719 | |
United States, California | |
Western University Health Sciences | |
Pomona, California, United States, 91766 | |
United States, District of Columbia | |
Georgetown University Medical Center | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Memorial Healthcare System | |
Hollywood, Florida, United States, 33021 | |
United States, Georgia | |
Aiyan Diabetes Center | |
Evans, Georgia, United States, 30809 | |
United States, Idaho | |
Elks Wound Center | |
Meridian, Idaho, United States, 83642 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
North Shore Long Island Jewish Health System | |
Lake Success, New York, United States, 10042 | |
Bellevue Hospital | |
New York, New York, United States, 10016 | |
Metropolitan Hospital | |
New York, New York, United States, 10029 | |
Lincoln Hospital | |
New York, New York, United States, 10451 | |
United States, Texas | |
University of Texas Southwestern Medical Center | |
Dallas, Texas, United States, 75390 |
Principal Investigator: | Stephen M Warren, MD | NYU School of Medicine |
Responsible Party: | Stephen Warren, Principal Investigator, NYU Langone Health |
ClinicalTrials.gov Identifier: | NCT01371318 |
Other Study ID Numbers: |
R01HS019218-01 ( U.S. AHRQ Grant/Contract ) |
First Posted: | June 10, 2011 Key Record Dates |
Last Update Posted: | December 31, 2014 |
Last Verified: | December 2014 |
diabetic foot ulcer amputation wounds diabetic foot diabetes complications |
Diabetic Foot Foot Ulcer Diabetes Complications Wounds and Injuries Diabetes Mellitus Endocrine System Diseases Diabetic Angiopathies |
Vascular Diseases Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases Diabetic Neuropathies Foot Diseases |