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

This study is currently recruiting participants.
Verified April 2013 by New York University School of Medicine
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: April 16, 2013
Last verified: April 2013
  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 ]

Estimated Enrollment: 4800
Study Start Date: July 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371318

Contacts
Contact: Stephen M Warren, MD 212-263-2155 stephen.warren@nyumc.org
Contact: Carla Alamia, BS 212-263-4355 carla.alamia@nyumc.org

Locations
United States, Arizona
Phoenix VA Hospital Recruiting
Phoenix, Arizona, United States, 85012
Contact: Robert Frkyberg, DPM    602-277-5551 ext 2866    robert.frykberg@va.gov   
Principal Investigator: Robert Frykberg, DPM         
University of Arizona Recruiting
Tuscon, Arizona, United States, 85719
Contact: David Armstrong    520-626-1349    mwatchman@surgery.arizona.edu   
Principal Investigator: David Armnstrong, MD         
United States, California
Western University Health Sciences Recruiting
Pomona, California, United States, 91766
Contact: Lawrence Harkless, DPM    909-706-3877    lharkless@western.edu   
Principal Investigator: Lawrence Harkless, DPM         
United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Christoper Attinger, MD    202-444-3059    cattinger@aol.com   
Contact: Mallory Nicholls    202-444-6735    mallory.w.nichols@gunet.georgetown.edu   
Sub-Investigator: Paul Kim, DPM         
United States, Florida
Memorial Healthcare System Recruiting
Hollywood, Florida, United States, 33021
Contact: Sean O'Donnell, MD    954-265-4664    sean.vascular@gmail.com   
Principal Investigator: Sean O'Donnell, MD         
United States, Georgia
Aiyan Diabetes Center Recruiting
Evans, Georgia, United States, 30809
Contact: JayBalan Sivakumar    706-868-0319    chola_jk@yahoo.com   
Principal Investigator: Janaki Nadarajah, DPM         
United States, Idaho
Elks Wound Center Recruiting
Meridian, Idaho, United States, 83642
Contact: Lydia Nixt    208-489-5835    LNixt@elksrehab.org   
Principal Investigator: Warren Gude, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tyson Scraybeck, MD       scraybeck.tyson@mayo.edu   
Principal Investigator: Karen Andrews, MD         
United States, New York
North Shore Long Island Jewish Health System Recruiting
Lake Success, New York, United States, 10042
Contact: Alisha Oropallo, MD    516-233-3780    Aoropallo@nshs.edu   
Principal Investigator: Alisha Oropallo, MD         
Bellevue Hospital Recruiting
New York, New York, United States, 10016
Contact: Stephen M Warren, MD    212-263-2155    stephen.warren@nyumc.org   
Contact: Carla Alamia, BS    212-263-4355    carla.alamia@nyumc.org   
Sub-Investigator: Alfred Garofolo, DPM         
Lincoln Hospital Recruiting
New York, New York, United States, 10451
Contact: Jay Yelon, M.D    718-579-5900      
Contact: Jennifer Melendez    718-579-6067    Jennifer.Melendez@nychhc.org   
Principal Investigator: Jay Yelon, M.D.         
Metropolitan Hospital Recruiting
New York, New York, United States, 10029
Contact: Khurram Khan, DPM    212-410-8424    kkhan@nycpm.edu   
Principal Investigator: Khurram Khan, DPM         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Lawrence Lavery, M.D    214-645-2257      
Contact: Deanna Adams, RN    214-645-8907    deanna.adams@utsouthwestern.edu   
Principal Investigator: Lawrence Lavery, MD         
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: April 16, 2013
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 Mellitus
Ulcer
Foot Ulcer
Diabetic Foot
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on April 23, 2014