WEMR With Clinical Decision Support for Diabetic Foot Ulcers
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|ClinicalTrials.gov Identifier: NCT02055755|
Recruitment Status : Unknown
Verified September 2016 by Harold Brem, MD, Winthrop University Hospital.
Recruitment status was: Recruiting
First Posted : February 5, 2014
Last Update Posted : September 13, 2016
The goal of this project to begin using a wound research database with clinical decision support features at Winthrop University Hospital. A research database is an electronic computer system that is used to collect patient information. Clinical decision support is the ability for a computer system to provide medical assistance to the doctor through alerts and recommendations based on the information entered. The investigators believe that use of a wound clinical decision support tool, much like a drug, will improve healing in patients diagnosed with Diabetic Foot Ulcers and ultimately lower the risk of death and illness caused by these wounds. In order to develop a useful clinical decision support tool, investigators first need to develop a large research database to determine the data points important for wound healing. The investigators will be using the data collected in this study for future research and publication. Data will be reviewed to answer questions important to diabetic foot ulcer healing and for the purpose of developing the clinical decision support alert system.
After providing informed consent, participants will be asked a series of questions related to their past medical history, and relevant wound data will be collected. Study staff will photograph the wound at baseline, and once per week until the wound is completely healed, or for a duration of six months.
Participants will be expected to return to Winthrop University Hospital for wound follow-up on a regular basis, or as determined by the Principal Investigator.
|Condition or disease|
|Diabetic Foot Ulcers|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Wound Research Database With Clinical Decision Support for Patients With Diabetic Foot Ulcers|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2020|
- Questionnaire relevant to wound healing [ Time Frame: up to 6 months ]
- How do different types of bacterial infections affect DFU healing?
- Does informing the patient and their families about wound characteristics improve DFU healing?
- Which treatment modalities are the most optimal for managing patients with complicated DFUs (e.g. ischemic, infected)?
- How does providing the patient with an individualized data summary and photos of their wound affect wound healing?
- Develop new parameters for clinical decision support based on data collected in this study. [ Time Frame: up to 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055755
|Contact: Julie DiGregorio, CCRP||(516) firstname.lastname@example.org|
|United States, New York|
|Winthrop University Hospital||Recruiting|
|Mineola, New York, United States, 11501|
|Contact: Julie DiGregorio, CCRP 516-663-9614 email@example.com|
|Principal Investigator: Harold Brem, MD|
|Sub-Investigator: Scott Gorenstein, MD|
|Sub-Investigator: Shayan Shirazian, MD|
|Sub-Investigator: Julie DiGregorio, CCRP|
|Principal Investigator:||Harold Brem, MD||Winthrop University Hospital|