Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

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.

Condition or disease
Diabetic Foot Ulcers

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. Develop new parameters for clinical decision support based on data collected in this study. [ Time Frame: up to 6 months ]

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.

Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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:

  • None

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 identifier (NCT number): NCT02055755

Layout table for location contacts
Contact: Julie DiGregorio, CCRP (516) 663-9614

Layout table for location information
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Julie DiGregorio, CCRP    516-663-9614   
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
Layout table for investigator information
Principal Investigator: Harold Brem, MD Winthrop University Hospital
Additional Information:
Layout table for additonal information
Responsible Party: Harold Brem, MD, Chief, Division of Wound Healing and Regenerative Medicine, Winthrop University Hospital Identifier: NCT02055755    
Other Study ID Numbers: 13309-1
First Posted: February 5, 2014    Key Record Dates
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:
Layout table for 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