Clinical trial NCT01371318: Online Wound Electronic Medical Record (OWEMR) to Decrease Amputations in Diabetics
Official title: Wound EMR to Decrease Limb Amputations in Persons With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds
Diabetes Complications
Diabetic Foot
Foot Ulcer
Keywords: diabetic foot ulcer
amputation
wounds
diabetic foot
diabetes complications
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2011-06-10
Enrollment: 1609
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Lower extremity amputation secondary to diabetic foot ulcer
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Hospital
state: Arizona
city: Tuscon
country: United States
facility: University of Arizona
state: Arizona
city: Pomona
country: United States
facility: Western University Health Sciences
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Evans
country: United States
facility: Aiyan Diabetes Center
state: Georgia
city: Meridian
country: United States
facility: Elks Wound Center
state: Idaho
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Lake Success
country: United States
facility: North Shore Long Island Jewish Health System
state: New York
city: New York
country: United States
facility: Bellevue Hospital
state: New York
city: New York
country: United States
facility: Metropolitan Hospital
state: New York
city: New York
country: United States
facility: Lincoln Hospital
state: New York
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: NYU School of Medicine
name: Stephen M Warren, MD
role: PRINCIPAL_INVESTIGATOR
References: