Assessment of the Potential for Pressure Ulcer Formation

Pressure Ulcer Not Visible Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01770717
• Other study ID #: 20128868
• Status: Withdrawn
• Start date: August 2012
• Est. completion date: August 2018

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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%).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcer Not Visible
• Ulcer

Intervention

Other:
• Spatial Frequency Domain Imaging
Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging

Locations

Country	Name	City	State
United States	UCIMC	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Formation of Pressure Ulcer	Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging	up to 6 months