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WEMR With Clinical Decision Support for Diabetic Foot Ulcers

Wound Research Database With Clinical Decision Support for Patients With Diabetic Foot Ulcers

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02055755
Enrollment
0
Registered
2014-02-05
Start date
2013-04-30
Completion date
2018-04-01
Last updated
2023-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcers

Keywords

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

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.

Interventions

None listed

Sponsors

Winthrop University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Questionnaire relevant to wound healingup 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

MeasureTime frame
Develop new parameters for clinical decision support based on data collected in this study.up to 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026