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Assessment of the Potential for Pressure Ulcer Formation

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ClinicalTrials.gov Identifier: NCT01770717
Recruitment Status : Recruiting
First Posted : January 18, 2013
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

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%).

Condition or disease Intervention/treatment
Pressure Ulcer Not Visible Other: Spatial Frequency Domain Imaging

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 Design

Study Type : Observational
Estimated Enrollment : 175 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Assessment of the Potential for Pressure Ulcer Formation Using a New Optical Imaging Technology: Spatial Frequency Domain Imaging
Study Start Date : August 2012
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Pressure Ulcer Formation
Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging
Other: Spatial Frequency Domain Imaging
Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging

Outcome Measures

Primary Outcome Measures :
  1. Formation of Pressure Ulcer [ Time Frame: up to 6 months ]
    Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study polpulation will be selected from UCIMC Inpatient care unit

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770717

Contact: Nicole Bernal, MD (714) 456-5890 bernaln@uci.edu
Contact: Seyed Ataollah Sharif, MD 949.824-9265 sharifs@uci.edu

United States, California
UCIMC Recruiting
Orange, California, United States, 92868
Contact: Nicole Bernal, MD    714-456-5890    bernaln@uci.edu   
Contact: Ata Sharif, MD    949.824.9265    sharifs@uci.edu   
Sub-Investigator: Nicole Bernal, MD         
Sub-Investigator: Allen Kong, MD         
Sub-Investigator: Cristobal Barrios, MD         
Sub-Investigator: Christopher Lane, MD         
Sub-Investigator: Ata Sharif, MD         
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Principal Investigator: Anthony Durkin, PhD Beckman Laser Institute, UCI
More Information

Responsible Party: Beckman Laser Institute and Medical Center, Anthony Durkin, Ph.D. Associate Professor, Director, Laboratory for Functional Imaging and Spectroscopy of Superficial Tissues, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01770717     History of Changes
Other Study ID Numbers: NIH/LAMMP-2012-8868
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases