Assessment of the Potential for Pressure Ulcer Formation

Withdrawn

• Conditions: Pressure Ulcer Not Visible
• Interventions: Other: Spatial Frequency Domain Imaging

• Registration Number: NCT01770717
• Lead Sponsor: University of California, Irvine

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%).

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-18
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pressure Ulcer Formation	Spatial Frequency Domain Imaging	Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging

Primary Outcome Measures

Name	Time	Method
Formation of Pressure Ulcer	up to 6 months	Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging

Trial Locations

Locations (1)

UCIMC; 🇺🇸 Orange, California, United States