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

Diabetic Foot Clinical Trial

— OWEMR  

Official title:

Wound EMR to Decrease Limb Amputations in Persons With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371318
• Other study ID #: R01HS019218-01
• Status: Completed
• Phase: N/A
• First received: June 9, 2011
• Last updated: December 29, 2014
• Start date: July 2011
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1609
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetic Foot
• Foot Ulcer
• Wounds

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Aiyan Diabetes Center	Evans	Georgia
United States	Memorial Healthcare System	Hollywood	Florida
United States	North Shore Long Island Jewish Health System	Lake Success	New York
United States	Elks Wound Center	Meridian	Idaho
United States	Bellevue Hospital	New York	New York
United States	Lincoln Hospital	New York	New York
United States	Metropolitan Hospital	New York	New York
United States	Phoenix VA Hospital	Phoenix	Arizona
United States	Western University Health Sciences	Pomona	California
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Arizona	Tuscon	Arizona
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower extremity amputation secondary to diabetic foot ulcer		6 months	No

External Links

•   Comparative Effectiveness Research