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WEMR With Clinical Decision Support for Diabetic Foot Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Harold Brem, MD, Winthrop University Hospital

Tracking Information
First Submitted Date January 31, 2014
First Posted Date February 5, 2014
Last Update Posted Date September 13, 2016
Study Start Date April 2013
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 4, 2014)
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?
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 4, 2014)
Develop new parameters for clinical decision support based on data collected in this study. [ Time Frame: up to 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title WEMR With Clinical Decision Support for Diabetic Foot Ulcers
Official Title Wound Research Database With Clinical Decision Support for Patients With Diabetic Foot Ulcers
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Male or female patients at Winthrop University Hospital diagnosed with a Diabetic Foot Ulcer.
Condition Diabetic Foot Ulcers
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 4, 2014)
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2020
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age ≥ 21
  • Diabetes Type I, or Type II
  • Must have a break in the skin on the plantar aspect of foot, > 0.5cm2
  • Willing and able to provide written Informed Consent

Exclusion Criteria:

  • None
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT02055755
Other Study ID Numbers 13309-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Harold Brem, MD, Winthrop University Hospital
Study Sponsor Winthrop University Hospital
Collaborators Not Provided
Principal Investigator: Harold Brem, MD Winthrop University Hospital
PRS Account Winthrop University Hospital
Verification Date September 2016