WEMR With Clinical Decision Support for Diabetic Foot Ulcers

NCT02055755 | Withdrawn

• 1 other identifier: 13309-1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcers

Keywords

Diabetes; Wounds; Wound Healing; Diabetic Foot Ulcer; DFU; Clinical Decision Support

Outcome Measures

Primary Outcomes (1)

• Questionnaire relevant to wound healing

  * 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?

  up to 6 months

Secondary Outcomes (1)

• Develop new parameters for clinical decision support based on data collected in this study.

  up to 6 months

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female patients at Winthrop University Hospital diagnosed with a Diabetic Foot Ulcer.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Winthrop University Hospital: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Wounds and Injuries

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Harold Brem, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 5, 2014
• Study Start: April 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 26, 2023

Record last verified: 2016-09

Locations

US (1)