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WithdrawnNCT02055599Updated Apr 26, 2023

WEMR With Clinical Decision Support for All Wounds

An observational study in Chronic Wounds, sponsored by Winthrop University Hospital. Withdrawn at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-04-26.

Sponsored by Winthrop University Hospital · Observational

Why this study was withdrawn
PI departure.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
21 Years and older
Sex
All
01

Study 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 with chronic wounds (wounds that fail to heal over the course of weeks) 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 wound 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.

02

Conditions studied

  • Chronic Wounds

Keywords

  • Wound
  • Wound Healing
  • Pressure Ulcers
  • Chronic Wounds
  • Clinical Decision Support
03

In context

Wounds and Injuries

2,217 studies on the registry are indexed under Wounds and Injuries; 440 are open to participants now.

Browse Wounds and Injuries studies →

Lead sponsor

Winthrop University Hospital is the lead sponsor of 42 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Male or female patients at Winthrop University Hospital with any chronic wound (defined as a break in the integument).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 21 years or older
  • Diagnosed with a wound (defined as a break in the integument)
  • Must be willing and able to provide written

Exclusion criteria

Exclusion Criteria:

  • Patients with Diabetic Foot Ulcers
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. To answer questions relevant to wound healing.

    * How does wound pathology relate to wound healing? * How do different types of bacterial infections affect wound healing? * To determine the etiology of morbidity, mortality and cost in chronic wound patients. * How does providing the patient with an individualized data summary and photos of their wound affect wound healing?

    Time frame: up to 6 months

Secondary outcomes

  1. Develop new parameters for clinical decision support based on wound data collected.

    Time frame: up to 6 months

07

Study locations

1 site
  • Winthrop University Hospital
    Mineola, New York 11501, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2013, a primary completion of Apr 2018 and a completion of Apr 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2014
First posted
Feb 5, 2014
Start
Apr 2013
Primary completionActual
Apr 1, 2018
CompletionActual
Apr 1, 2018
Last update
Apr 26, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02055599
Lead sponsor
Winthrop University Hospital
Responsible party
Sponsor
First posted
Feb 5, 2014
Start date
Apr 2013
Primary completion
Apr 1, 2018
Completion
Apr 1, 2018
Last update
Apr 26, 2023

Study contacts

Harold Brem, MD
principal investigator · Winthrop University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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