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WEMR With Clinical Decision Support for Diabetic Foot Ulcers

This study is currently recruiting participants.
Verified September 2016 by Harold Brem, MD, Winthrop University Hospital
ClinicalTrials.gov Identifier:
First Posted: February 5, 2014
Last Update Posted: September 13, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Harold Brem, MD, Winthrop University Hospital

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.

Diabetic Foot Ulcers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Wound Research Database With Clinical Decision Support for Patients With Diabetic Foot Ulcers

Resource links provided by NLM:

Further study details as provided by Harold Brem, MD, Winthrop University Hospital:

Primary Outcome Measures:
  • 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?

Secondary Outcome Measures:
  • Develop new parameters for clinical decision support based on data collected in this study. [ Time Frame: up to 6 months ]

Estimated Enrollment: 500
Study Start Date: April 2013
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male or female patients at Winthrop University Hospital diagnosed with a Diabetic Foot Ulcer.

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:

  Contacts and Locations
Information from the National Library of Medicine

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) 663-9614 jdigregorio@winthrop.org

United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Julie DiGregorio, CCRP    516-663-9614    jdigregorio@winthrop.org   
Principal Investigator: Harold Brem, MD         
Sub-Investigator: Scott Gorenstein, MD         
Sub-Investigator: Shayan Shirazian, MD         
Sub-Investigator: Julie DiGregorio, CCRP         
Sponsors and Collaborators
Winthrop University Hospital
Principal Investigator: Harold Brem, MD Winthrop University Hospital
  More Information

Additional Information:
Responsible Party: Harold Brem, MD, Chief, Division of Wound Healing and Regenerative Medicine, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT02055755     History of Changes
Other Study ID Numbers: 13309-1
First Submitted: January 31, 2014
First Posted: February 5, 2014
Last Update Posted: September 13, 2016
Last Verified: September 2016

Keywords provided by Harold Brem, MD, Winthrop University Hospital:
Wound Healing
Diabetic Foot Ulcer
Clinical Decision Support

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases