Online Wound Electronic Medical Record (OWEMR) to Decrease Amputations in Diabetics
This study has been completed.
Sponsor:
New York University School of Medicine
Collaborator:
Information provided by (Responsible Party):
Stephen Warren, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01371318
First received: June 9, 2011
Last updated: December 29, 2014
Last verified: December 2014
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Wounds Diabetes Complications Diabetic Foot Foot Ulcer |
Other: Online Wound Electronic Medical Record |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Wound EMR to Decrease Limb Amputations in Persons With Diabetes |
Resource links provided by NLM:
Further study details as provided by New York University School of Medicine:
Primary Outcome Measures:
- Lower extremity amputation secondary to diabetic foot ulcer [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 1609 |
| Study Start Date: | July 2011 |
| Study Completion Date: | September 2014 |
| Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
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
|
|
No Intervention: Standard of Care
Medical/wound centers will be randomized to continue routine care of patients with diabetic foot ulcers
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371318
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371318
Locations
| United States, Arizona | |
| Phoenix VA Hospital | |
| Phoenix, Arizona, United States, 85012 | |
| University of Arizona | |
| Tuscon, Arizona, United States, 85719 | |
| United States, California | |
| Western University Health Sciences | |
| Pomona, California, United States, 91766 | |
| United States, District of Columbia | |
| Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Memorial Healthcare System | |
| Hollywood, Florida, United States, 33021 | |
| United States, Georgia | |
| Aiyan Diabetes Center | |
| Evans, Georgia, United States, 30809 | |
| United States, Idaho | |
| Elks Wound Center | |
| Meridian, Idaho, United States, 83642 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New York | |
| North Shore Long Island Jewish Health System | |
| Lake Success, New York, United States, 10042 | |
| Bellevue Hospital | |
| New York, New York, United States, 10016 | |
| Lincoln Hospital | |
| New York, New York, United States, 10451 | |
| Metropolitan Hospital | |
| New York, New York, United States, 10029 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
Sponsors and Collaborators
New York University School of Medicine
Investigators
| Principal Investigator: | Stephen M Warren, MD | NYU School of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Stephen Warren, Principal Investigator, New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01371318 History of Changes |
| Other Study ID Numbers: | R01-HS019218-01 |
| Study First Received: | June 9, 2011 |
| Last Updated: | December 29, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York University School of Medicine:
|
diabetic foot ulcer amputation wounds diabetic foot diabetes complications |
Additional relevant MeSH terms:
|
Diabetes Complications Diabetic Foot Cardiovascular Diseases Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies |
Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Vascular Diseases |
ClinicalTrials.gov processed this record on February 27, 2015