WoundsOWEMRNCT01371318
Online Wound Electronic Medical Record (OWEMR) to Decrease Amputations in Diabetics
A study testing Online Wound Electronic Medical Record in people with Wounds and Diabetes Complications, run by NYU Langone Health at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds, Diabetes Complications, Diabetic Foot
- What is being tested?
- Online Wound Electronic Medical Record
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,609 participants
- Where
- 13 sitesUnited States
- Study dates
- Jul 2011to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Aiyan Diabetes Center
Evans, Georgia, 30809
Memorial Healthcare System
Hollywood, Florida, 33021
North Shore Long Island Jewish Health System
Lake Success, New York, 10042
Elks Wound Center
Meridian, Idaho, 83642
Bellevue Hospital
New York, New York, 10016
Metropolitan Hospital
New York, New York, 10029
Lincoln Hospital
New York, New York, 10451
Phoenix VA Hospital
Phoenix, Arizona, 85012
Western University Health Sciences
Pomona, California, 91766
Mayo Clinic
Rochester, Minnesota, 55905
University of Arizona
Tuscon, Arizona, 85719
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Wound EMR to Decrease Limb Amputations in Persons With Diabetes
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.
- Conditions
- Wounds, Diabetes Complications, Diabetic Foot, Foot Ulcer
- Being tested
- Online Wound Electronic Medical Record
- Keywords
- diabetic foot ulcer, amputation, wounds, diabetic foot, diabetes complications
- Medical subject headings
- Wounds and Injuries, Diabetes Complications, Diabetic Foot, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Wound Electronic Medical RecordOther
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
| Study group | Role | What they receive |
|---|---|---|
| OWEMR | Experimental | Medical centers will be randomized to use the Online Wound Electronic Medical Record to enhance care of patients with diabetic foot ulcers Receives: Other: Online Wound Electronic Medical Record |
| Standard of Care | No intervention | Medical/wound centers will be randomized to continue routine care of patients with diabetic foot ulcers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity amputation secondary to diabetic foot ulcer
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,609 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Stephen Warren, NYU Langone Health
- Investigators
- Stephen M Warren, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371318
- Sponsor's protocol ID
- R01HS019218-01
- Acronym
- OWEMR
- Status last verified
- Dec 2014
- First submitted
- 9 Jun 2011
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound EMR to Decrease Limb Amputations in Persons With Diabetes
- ClinicalTrials.gov ID
- NCT01371318
- Acronym / sponsor ID
- OWEMR / R01HS019218-01
- Conditions
- Wounds, Diabetes Complications, Diabetic Foot, Foot Ulcer
- Keywords
- diabetic foot ulcer, amputation, wounds, diabetic foot, diabetes complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,609 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jul 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OWEMR | Experimental | Other: Online Wound Electronic Medical RecordMedical centers will be randomized to use the Online Wound Electronic Medical Record to enhance care of patients with diabetic foot ulcers |
| Standard of Care | No intervention | –Medical/wound centers will be randomized to continue routine care of patients with diabetic foot ulcers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Wound Electronic Medical RecordOnline 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 | Other | OWEMR |
Primary outcome
Lower extremity amputation secondary to diabetic foot ulcer
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
- Comparative Effectiveness ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen M Warren, MD principal investigator
NYU School of Medicine
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Wound Electronic Medical Record in people with Wounds and Diabetes Complications, run by NYU Langone Health at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity amputation secondary to diabetic foot ulcer (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.