Viewing Study NCT01371318


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Study NCT ID: NCT01371318
Status: COMPLETED
Last Update Posted: 2014-12-31
First Post: 2011-06-09
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Online Wound Electronic Medical Record (OWEMR) to Decrease Amputations in Diabetics
Sponsor: NYU Langone Health
Organization:

Study Overview

Official Title: Wound EMR to Decrease Limb Amputations in Persons With Diabetes
Status: COMPLETED
Status Verified Date: 2014-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: OWEMR
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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: