WEMR With Clinical Decision Support for Diabetic Foot Ulcers

Sponsor

Winthrop University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02055755

Collaborator

(none)

500

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Diabetic Foot Ulcers

Study Design

Study Type:

Observational

Anticipated 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 :

Apr 1, 2013

Anticipated Primary Completion Date :

Apr 1, 2018

Anticipated Study Completion Date :

Apr 1, 2020

Outcome Measures

Primary Outcome Measures

Questionnaire relevant to wound healing [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?