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Assessment of the Potential for Pressure Ulcer Formation

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01770717
First received: January 14, 2013
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Pressure Ulcer Not Visible
 Device: Spatial Frequency Domain Imaging

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Assessment of the Potential for Pressure Ulcer Formation using a new optical imaging technology: Spatial Frequency Domain Imaging (SFDI) [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 175
Study Start Date: August 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Spatial Frequency Domain Imaging
    Assessment of the Potential for Pressure Ulcer Formation
Detailed Description:

Researchers at the Beckman Laser Institute at the University of California, Irvine invented and 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 SFDI imaging can identify metabolic and biochemical differences in the tissues near bony prominences which are at risk for developing pressure ulcers.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Inpatient care unit

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01770717

Locations
United States, California
UCIMC
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Anthony Durkin, PhD Beckman Laser Institute, UCI
  More Information

No publications provided

Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT01770717     History of Changes
Other Study ID Numbers: LAMMP-33029
Study First Received: January 14, 2013
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013