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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01371318
Other study ID # R01HS019218-01
Secondary ID
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


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
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