Pressure Ulcer Clinical Trial
Official title:
Thermal Imaging to Identify Distinct Temperature Patterns in Various Stages of Pressure Ulcers
40 patients total with pressure ulcers with a decubitus pressure ulcer will be included in this study. Ten patients with a Stage I, II, III, and IV decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera. Thermal imaging of the various stages of pressure ulcer will be analyzed to determine if a recognizable pattern of thermal distribution can be identified which can then be applied to identify patients at risk of developing pressure ulcers at an earlier stage in their hospital course.
This study will be a single-center prospective Phase I study in which the use of a thermal
imaging camera will be used to obtain imaging data on decubitus ulcers of various stages. The
data collected during this study will be used to determine if stage-specific thermal
distribution patterns can be identified. This information will then be used to design future
studies in which patients are risk for the development of pressure ulcers are screened for
the presence of pressure ulcers not detectable upon physical examination so that preventative
measures and treatments can be instituted.
A total of 40 patients with pressure decubitus ulcers will be recruited for inclusion in this
study. The investigators plan to enroll ten patients with each stage of pressure ulcer (i.e.
Stage I-IV), which will provide the investigators with a set of thermal imaging data from
which the investigators will determine if thermal distribution patterns unique to each stage
of pressure ulcer can be identified. It is anticipated that 40 patients who meet the
inclusion criteria and distribution of pressure ulcer staging will be enrolled within one
year of the start date of this study.
The investigators are planning a study of a continuous response variable from independent
control and experimental subjects with 1 control(s) per experimental subject. It is estimated
that the response within each subject group will be normally distributed with standard
deviation 25. If the true difference in the experimental and control means is 35, the
investigators will need to study 9 experimental subjects and 9 control subjects to be able to
reject the null hypothesis that the population means of the experimental and control groups
are equal with probability (power) 0.8. The Type I error probability associated with this
test of this null hypothesis is 0.05.
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