Trial record 1 of 292 for:
Open Studies | "Diabetes Complications"
Online Wound Electronic Medical Record (OWEMR) to Decrease Amputations in Diabetics
This study is currently recruiting participants.
Verified April 2013 by New York University School of Medicine
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: April 16, 2013
Last verified: April 2013
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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 ]
| Estimated Enrollment: | 4800 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371318
Contacts
| Contact: Stephen M Warren, MD | 212-263-2155 | stephen.warren@nyumc.org |
| Contact: Carla Alamia, BS | 212-263-4355 | carla.alamia@nyumc.org |
Locations
| United States, Arizona | |
| Phoenix VA Hospital | Recruiting |
| Phoenix, Arizona, United States, 85012 | |
| Contact: Robert Frkyberg, DPM 602-277-5551 ext 2866 robert.frykberg@va.gov | |
| Principal Investigator: Robert Frykberg, DPM | |
| University of Arizona | Recruiting |
| Tuscon, Arizona, United States, 85719 | |
| Contact: David Armstrong 520-626-1349 mwatchman@surgery.arizona.edu | |
| Principal Investigator: David Armnstrong, MD | |
| United States, California | |
| Western University Health Sciences | Recruiting |
| Pomona, California, United States, 91766 | |
| Contact: Lawrence Harkless, DPM 909-706-3877 lharkless@western.edu | |
| Principal Investigator: Lawrence Harkless, DPM | |
| United States, District of Columbia | |
| Georgetown University Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Christoper Attinger, MD 202-444-3059 cattinger@aol.com | |
| Contact: Mallory Nicholls 202-444-6735 mallory.w.nichols@gunet.georgetown.edu | |
| Sub-Investigator: Paul Kim, DPM | |
| United States, Florida | |
| Memorial Healthcare System | Recruiting |
| Hollywood, Florida, United States, 33021 | |
| Contact: Sean O'Donnell, MD 954-265-4664 sean.vascular@gmail.com | |
| Principal Investigator: Sean O'Donnell, MD | |
| United States, Georgia | |
| Aiyan Diabetes Center | Recruiting |
| Evans, Georgia, United States, 30809 | |
| Contact: JayBalan Sivakumar 706-868-0319 chola_jk@yahoo.com | |
| Principal Investigator: Janaki Nadarajah, DPM | |
| United States, Idaho | |
| Elks Wound Center | Recruiting |
| Meridian, Idaho, United States, 83642 | |
| Contact: Lydia Nixt 208-489-5835 LNixt@elksrehab.org | |
| Principal Investigator: Warren Gude, MD | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Tyson Scraybeck, MD scraybeck.tyson@mayo.edu | |
| Principal Investigator: Karen Andrews, MD | |
| United States, New York | |
| North Shore Long Island Jewish Health System | Recruiting |
| Lake Success, New York, United States, 10042 | |
| Contact: Alisha Oropallo, MD 516-233-3780 Aoropallo@nshs.edu | |
| Principal Investigator: Alisha Oropallo, MD | |
| Bellevue Hospital | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Stephen M Warren, MD 212-263-2155 stephen.warren@nyumc.org | |
| Contact: Carla Alamia, BS 212-263-4355 carla.alamia@nyumc.org | |
| Sub-Investigator: Alfred Garofolo, DPM | |
| Lincoln Hospital | Recruiting |
| New York, New York, United States, 10451 | |
| Contact: Jay Yelon, M.D 718-579-5900 | |
| Contact: Jennifer Melendez 718-579-6067 Jennifer.Melendez@nychhc.org | |
| Principal Investigator: Jay Yelon, M.D. | |
| Metropolitan Hospital | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Khurram Khan, DPM 212-410-8424 kkhan@nycpm.edu | |
| Principal Investigator: Khurram Khan, DPM | |
| United States, Texas | |
| University of Texas Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Lawrence Lavery, M.D 214-645-2257 | |
| Contact: Deanna Adams, RN 214-645-8907 deanna.adams@utsouthwestern.edu | |
| Principal Investigator: Lawrence Lavery, MD | |
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: | April 16, 2013 |
| 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 Diabetes Mellitus Ulcer Foot Ulcer Diabetic Foot Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pathologic Processes |
Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetic Neuropathies |
ClinicalTrials.gov processed this record on May 16, 2013