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Online Wound Electronic Medical Record (OWEMR) to Decrease Amputations in Diabetics (OWEMR)

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ClinicalTrials.gov Identifier: NCT01371318
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : December 31, 2014
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Stephen Warren, NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Wounds Diabetes Complications Diabetic Foot Foot Ulcer Other: Online Wound Electronic Medical Record Not Applicable

Detailed Description:
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.
Study Design
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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

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Arms and Interventions
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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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Lower extremity amputation secondary to diabetic foot ulcer [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
NYU Langone Health
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Stephen M Warren, MD NYU School of Medicine
More Information
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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
Keywords provided by Stephen Warren, NYU Langone Health:
diabetic foot ulcer
amputation
wounds
diabetic foot
diabetes complications
Additional relevant MeSH terms:
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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