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CompletedNCT01371318OWEMRUpdated Dec 31, 2014

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

An interventional study of Online Wound Electronic Medical Record in Wounds, Diabetes Complications and Diabetic Foot, sponsored by NYU Langone Health. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-31.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
1,609
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Wounds
  • Diabetes Complications
  • Diabetic Foot
  • Foot Ulcer

Keywords

  • diabetic foot ulcer
  • amputation
  • wounds
  • diabetic foot
  • diabetes complications
03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's enrollment of 1,609 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,609 participants (actual)

Study arms

  • 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

  • No intervention
    Standard of Care

    Medical/wound centers will be randomized to continue routine care of patients with diabetic foot ulcers

Interventions

  • OtherOnline 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

06

What researchers measure

Primary outcomes

  1. Lower extremity amputation secondary to diabetic foot ulcer

    Time frame: 6 months

07

Study locations

13 sites
  • Phoenix VA Hospital
    Phoenix, Arizona 85012, United States
  • University of Arizona
    Tuscon, Arizona 85719, United States
  • Western University Health Sciences
    Pomona, California 91766, United States
  • Georgetown University Medical Center
    Washington, District of Columbia 20007, United States
  • Memorial Healthcare System
    Hollywood, Florida 33021, United States
  • Aiyan Diabetes Center
    Evans, Georgia 30809, United States
  • Elks Wound Center
    Meridian, Idaho 83642, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • North Shore Long Island Jewish Health System
    Lake Success, New York 10042, United States
  • Bellevue Hospital
    New York, New York 10016, United States
  • Metropolitan Hospital
    New York, New York 10029, United States
  • Lincoln Hospital
    New York, New York 10451, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01371318
Lead sponsor
NYU Langone Health
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
Responsible party
Stephen Warren (Principal Investigator, NYU Langone Health) — Principal investigator
First posted
Jun 10, 2011
Start date
Jul 2011
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Dec 31, 2014

Study contacts

Stephen M Warren, MD
principal investigator · NYU School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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