Skin Temperature Perception and Prosthetic Thermoregulation

NCT07215442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-10-10

No results posted yet for this study

Summary

To protect against excessive body temperatures, local thermoregulatory mechanisms include temperature sensory nerves (responsive to warm or cool stimuli) and vasomotors (muscles that constrict or dilate blood vessels). When the temperature changes occur, the temperature sensory nerves will detect "warm" or "cool" and communicate this sensation to the brain. This is called perceiving a sensation and will often elicit a behavioral change, such as donning additional clothes or moving to a different environment. Simultaneously, vasomotors will dilate or constrict to promote or prevent heat dissipation to the environment, respectively. As skin temperatures increase, perspiration may provide some thermal relief through evaporative cooling. However, the prostheses worn by individuals with lower limb amputations are impermeable to moisture and prevent evaporative cooling. Prosthetic materials are also excellent thermal insulators, contributing to skin temperature increases. Thermoregulation problems are compounded by diabetes, a common co-morbidity of many who experience lower limb amputation. For those who wear lower limb prostheses, many endure thermal discomfort.

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.

Conditions

  • Lower Limb Amputation Below Knee
  • Diabetes (DM)
  • Skin Temperature Change
  • Vascular Reactivity

Interventions

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • VA Puget Sound Health Care System

    lead FED

Principal Investigators

  • Glenn K Klute, PhD · VA Puget Sound Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-28
Primary Completion
2013-08-09
Completion
2013-08-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07215442 on ClinicalTrials.gov