Skin Temperature Perception and Prosthetic Thermoregulation
NCT ID: NCT07215442
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2011-04-28
2013-08-09
Brief Summary
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This research explores the relationship between skin temperature, perception, and thermoregulation. The investigators aim to discover the temperature at which individuals with lower limb amputation perceive warm and cool stimuli. The investigators also aim to discover the vascular response that occurs when temperature changes are perceived. The goals are to determine temperature sensation thresholds of the lower limb, vascular reactivity, and the effect of diabetes and amputation.
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Detailed Description
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To measure temperature perception, a thermode (a temperature changing device about the size of a coffee cup) will be placed on the lower leg of each participant. The thermode also included a laser Doppler flow meter, embedded in the center of the thermode, to measure blood flow in response to changes in skin temperature. The experimental protocol begins with the thermode set for 3 minutes at 30 °C, 32 °C, 34 °C, and 35 °C (random order). The temperature will then be either increased or decreased at a slow rate of 0.2 °C/sec until the participant perceives either a warming or cooling sensation. The analysis plan includes determining the threshold at which a temperature change was perceived relative to each initial temperature, whether there are differences in blood flow (vascular reactivity) when thermal stimuli are detected, and these measurements are altered by diabetes or amputation.
The general hypotheses are that these populations will have (1) different warm and cool temperature perception thresholds depending on the initial skin temperature and (2) different changes in skin blood flow as a function of their temperature perception thresholds.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Individuals without a diagnosis of diabetes
Warming stimulus starting at 30 C initial temperature
A warming stimulus starting at 30 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Warming stimulus starting at 32 C initial temperature
A warming stimulus starting at 32 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Warming stimulus starting at 34 C initial temperature
A warming stimulus starting at 34 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Warming stimulus starting at 35 C initial temperature
A warming stimulus starting at 35 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Cooling stimulus starting at 30 C initial temperature
A cooling stimulus starting at 30 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Cooling stimulus starting at 32 C initial temperature
A cooling stimulus starting at 32 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Cooling stimulus starting at 34 C initial temperature
A cooling stimulus starting at 34 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Cooling stimulus starting at 35 C initial temperature
A cooling stimulus starting at 35 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Individuals with diabetes
Warming stimulus starting at 30 C initial temperature
A warming stimulus starting at 30 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Warming stimulus starting at 32 C initial temperature
A warming stimulus starting at 32 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Warming stimulus starting at 34 C initial temperature
A warming stimulus starting at 34 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Warming stimulus starting at 35 C initial temperature
A warming stimulus starting at 35 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Cooling stimulus starting at 30 C initial temperature
A cooling stimulus starting at 30 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Cooling stimulus starting at 32 C initial temperature
A cooling stimulus starting at 32 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Cooling stimulus starting at 34 C initial temperature
A cooling stimulus starting at 34 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Cooling stimulus starting at 35 C initial temperature
A cooling stimulus starting at 35 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Individuals with lower limb amputations of diabetic etiology
Warming stimulus starting at 30 C initial temperature
A warming stimulus starting at 30 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Warming stimulus starting at 32 C initial temperature
A warming stimulus starting at 32 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Warming stimulus starting at 34 C initial temperature
A warming stimulus starting at 34 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Warming stimulus starting at 35 C initial temperature
A warming stimulus starting at 35 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Cooling stimulus starting at 30 C initial temperature
A cooling stimulus starting at 30 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Cooling stimulus starting at 32 C initial temperature
A cooling stimulus starting at 32 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Cooling stimulus starting at 34 C initial temperature
A cooling stimulus starting at 34 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Cooling stimulus starting at 35 C initial temperature
A cooling stimulus starting at 35 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Individuals with lower limb amputations of non-diabetic etiologies
Warming stimulus starting at 30 C initial temperature
A warming stimulus starting at 30 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Warming stimulus starting at 32 C initial temperature
A warming stimulus starting at 32 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Warming stimulus starting at 34 C initial temperature
A warming stimulus starting at 34 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Warming stimulus starting at 35 C initial temperature
A warming stimulus starting at 35 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Cooling stimulus starting at 30 C initial temperature
A cooling stimulus starting at 30 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Cooling stimulus starting at 32 C initial temperature
A cooling stimulus starting at 32 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Cooling stimulus starting at 34 C initial temperature
A cooling stimulus starting at 34 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Cooling stimulus starting at 35 C initial temperature
A cooling stimulus starting at 35 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Interventions
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Warming stimulus starting at 30 C initial temperature
A warming stimulus starting at 30 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Warming stimulus starting at 32 C initial temperature
A warming stimulus starting at 32 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Warming stimulus starting at 34 C initial temperature
A warming stimulus starting at 34 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Warming stimulus starting at 35 C initial temperature
A warming stimulus starting at 35 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 42 C was reached.
Cooling stimulus starting at 30 C initial temperature
A cooling stimulus starting at 30 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Cooling stimulus starting at 32 C initial temperature
A cooling stimulus starting at 32 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Cooling stimulus starting at 34 C initial temperature
A cooling stimulus starting at 34 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Cooling stimulus starting at 35 C initial temperature
A cooling stimulus starting at 35 C initial temperature was applied at a rate of 0.2 C/second until the participant perceived the stimulus or the termination temperature of 18 C was reached.
Eligibility Criteria
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Inclusion Criteria
* Able to attend study visits
* Able to sense a Semmes-Weinstein 5.07 monofilament applied to proximal lateral aspect of test limb calf
* Have been fit with a prosthesis
* Have used a prosthesis for at least six months
* Wear the prosthesis for at least four hours per day by self-report
Exclusion Criteria
18 Years
70 Years
ALL
Yes
Sponsors
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VA Puget Sound Health Care System
FED
Responsible Party
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Glenn K. Klute, PhD
Director, CLiMB
Principal Investigators
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Glenn K Klute, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System
Locations
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VA Puget Sound Health Care System Seattle Division
Seattle, Washington, United States
Countries
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Other Identifiers
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1587700
Identifier Type: -
Identifier Source: org_study_id
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