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

Primary Purpose

Wounds, Diabetes Complications, Diabetic Foot

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Wound Electronic Medical Record
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Wounds focused on measuring diabetic foot ulcer, amputation, wounds, diabetic foot, diabetes complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

  • Phoenix VA Hospital
  • University of Arizona
  • Western University Health Sciences
  • Georgetown University Medical Center
  • Memorial Healthcare System
  • Aiyan Diabetes Center
  • Elks Wound Center
  • Mayo Clinic
  • North Shore Long Island Jewish Health System
  • Bellevue Hospital
  • Metropolitan Hospital
  • Lincoln Hospital
  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

OWEMR

Standard of Care

Arm Description

Medical centers will be randomized to use the Online Wound Electronic Medical Record to enhance care of patients with diabetic foot ulcers

Medical/wound centers will be randomized to continue routine care of patients with diabetic foot ulcers

Outcomes

Primary Outcome Measures

Lower extremity amputation secondary to diabetic foot ulcer

Secondary Outcome Measures

Full Information

First Posted
June 9, 2011
Last Updated
December 29, 2014
Sponsor
NYU Langone Health
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT01371318
Brief Title
Online Wound Electronic Medical Record (OWEMR) to Decrease Amputations in Diabetics
Acronym
OWEMR
Official Title
Wound EMR to Decrease Limb Amputations in Persons With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NYU Langone Health
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds, Diabetes Complications, Diabetic Foot, Foot Ulcer
Keywords
diabetic foot ulcer, amputation, wounds, diabetic foot, diabetes complications

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1609 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OWEMR
Arm Type
Experimental
Arm Description
Medical centers will be randomized to use the Online Wound Electronic Medical Record to enhance care of patients with diabetic foot ulcers
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Medical/wound centers will be randomized to continue routine care of patients with diabetic foot ulcers
Intervention Type
Other
Intervention Name(s)
Online Wound Electronic Medical Record
Intervention 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
Primary Outcome Measure Information:
Title
Lower extremity amputation secondary to diabetic foot ulcer
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen M Warren, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix VA Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
University of Arizona
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Western University Health Sciences
City
Pomona
State/Province
California
ZIP/Postal Code
91766
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Memorial Healthcare System
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Aiyan Diabetes Center
City
Evans
State/Province
Georgia
ZIP/Postal Code
30809
Country
United States
Facility Name
Elks Wound Center
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
North Shore Long Island Jewish Health System
City
Lake Success
State/Province
New York
ZIP/Postal Code
10042
Country
United States
Facility Name
Bellevue Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Metropolitan Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Lincoln Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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

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