NCT01770717

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%).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

6 years

First QC Date

January 14, 2013

Last Update Submit

October 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Formation of Pressure Ulcer

    Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging

    up to 6 months

Study Arms (1)

Pressure Ulcer Formation

Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging

Other: Spatial Frequency Domain Imaging

Interventions

Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging

Pressure Ulcer Formation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study polpulation will be selected from UCIMC Inpatient care unit

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCIMC

Orange, California, 92868, United States

Location

Study Officials

  • Anthony Durkin, PhD

    Beckman Laser Institute, UCI

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anthony Durkin, Ph.D. Associate Professor, Director, Laboratory for Functional Imaging and Spectroscopy of Superficial Tissues

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 18, 2013

Study Start

August 1, 2012

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations