WEMR With Clinical Decision Support for Diabetic Foot Ulcers

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Winthrop University Hospital
Information provided by (Responsible Party):
Harold Brem, MD, Winthrop University Hospital
ClinicalTrials.gov Identifier:
First received: January 31, 2014
Last updated: December 7, 2015
Last verified: December 2015

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 Winthrop University Hospital:

Primary Outcome Measures:
  • Questionnaire relevant to wound healing [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]

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)

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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 
Study First Received: January 31, 2014
Last Updated: December 7, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
Wound Healing
Diabetic Foot Ulcer
Clinical Decision Support

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

ClinicalTrials.gov processed this record on February 04, 2016