Assessment of the Potential for Pressure Ulcer Formation

October 28, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine

Assessment of the Potential for Pressure Ulcer Formation Using a New Optical Imaging Technology: Spatial Frequency Domain Imaging

Pressure ulcers are a significant problem in institutionalized, elderly, and critically ill patients. Pressure ulcers result in significant pain, changing quality of life, and often leading to significant morbidity and prolonged hospital stays, and ultimately increased the healthcare cost.

According to the International Pressure Ulcer Prevalence Survey, the prevalence of hospital acquired pressure ulcers in the United States was 13.5% in 2008 and 12.8% in 2009. This survey also indicated that the highest rate of pressure ulcers is in the long term acute care population (22%).

Study Overview

Status

Withdrawn

Detailed Description

Researchers developed a non-contact optical imaging technology call Spatial Frequency Domain Imaging which can identify the tissue regions that are at risk of developing pressure ulcers prior to development of irreversible tissue damage. The Spatial Frequency Domain Imaging can identify metabolic and biochemical differences in the tissues near bony prominences which are at risk for developing pressure ulcers.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Orange, California, United States, 92868
        • UCIMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study polpulation will be selected from UCIMC Inpatient care unit

Description

Inclusion Criteria:

  • Male or female 18 years of age and older
  • Diagnose with potential of pressure ulcers

Exclusion Criteria:

  • No potential of pressure ulcers
  • Has history of vascular disease in both lower extremities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pressure Ulcer Formation
Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging
Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Formation of Pressure Ulcer
Time Frame: up to 6 months
Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anthony Durkin, PhD, Beckman Laser Institute, UCI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

January 14, 2013

First Submitted That Met QC Criteria

January 15, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 20128868

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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