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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephen Warren, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01371318
First received: June 9, 2011
Last updated: December 29, 2014
Last verified: December 2014
  Purpose

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 Intervention
Wounds
Diabetes Complications
Diabetic Foot
Foot Ulcer
Other: Online Wound Electronic Medical Record

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Wound EMR to Decrease Limb Amputations in Persons With Diabetes

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Lower extremity amputation secondary to diabetic foot ulcer [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 1609
Study Start Date: July 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01371318

Locations
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
Lincoln Hospital
New York, New York, United States, 10451
Metropolitan Hospital
New York, New York, United States, 10029
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Stephen M Warren, MD NYU School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Stephen Warren, Principal Investigator, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01371318     History of Changes
Other Study ID Numbers: R01-HS019218-01
Study First Received: June 9, 2011
Last Updated: December 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
diabetic foot ulcer
amputation
wounds
diabetic foot
diabetes complications

Additional relevant MeSH terms:
Diabetes Complications
Diabetic Foot
Foot Ulcer
Cardiovascular Diseases
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Leg Ulcer
Skin Diseases
Skin Ulcer
Vascular Diseases

ClinicalTrials.gov processed this record on July 27, 2015