Skin Temperature Perception and Prosthetic Thermoregulation

NCT07215442 | Completed

• 1 other identifier: 1587700
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Thermal perception threshold

  The thermal perception threshold is the difference between the initial temperature and the temperature at which the participant detected the thermal stimulus

  Day 1

• Skin blood flow difference

  The skin blood flow difference is the difference between the skin blood flow at the initial temperature and the skin blood flow at the temperature at which the participant detected a thermal stimulus

  Day 1

Study Arms (4)

Individuals without a diagnosis of diabetes

OTHER

Other: Warming stimulus starting at 30 C initial temperature; Other: Warming stimulus starting at 32 C initial temperature; Other: Warming stimulus starting at 34 C initial temperature; Other: Warming stimulus starting at 35 C initial temperature; Other: Cooling stimulus starting at 30 C initial temperature; Other: Cooling stimulus starting at 32 C initial temperature; Other: Cooling stimulus starting at 34 C initial temperature; Other: Cooling stimulus starting at 35 C initial temperature

Individuals with diabetes

OTHER

Other: Warming stimulus starting at 30 C initial temperature; Other: Warming stimulus starting at 32 C initial temperature; Other: Warming stimulus starting at 34 C initial temperature; Other: Warming stimulus starting at 35 C initial temperature; Other: Cooling stimulus starting at 30 C initial temperature; Other: Cooling stimulus starting at 32 C initial temperature; Other: Cooling stimulus starting at 34 C initial temperature; Other: Cooling stimulus starting at 35 C initial temperature

Individuals with lower limb amputations of diabetic etiology

OTHER

Other: Warming stimulus starting at 30 C initial temperature; Other: Warming stimulus starting at 32 C initial temperature; Other: Warming stimulus starting at 34 C initial temperature; Other: Warming stimulus starting at 35 C initial temperature; Other: Cooling stimulus starting at 30 C initial temperature; Other: Cooling stimulus starting at 32 C initial temperature; Other: Cooling stimulus starting at 34 C initial temperature; Other: Cooling stimulus starting at 35 C initial temperature

Individuals with lower limb amputations of non-diabetic etiologies

OTHER

Other: Warming stimulus starting at 30 C initial temperature; Other: Warming stimulus starting at 32 C initial temperature; Other: Warming stimulus starting at 34 C initial temperature; Other: Warming stimulus starting at 35 C initial temperature; Other: Cooling stimulus starting at 30 C initial temperature; Other: Cooling stimulus starting at 32 C initial temperature; Other: Cooling stimulus starting at 34 C initial temperature; Other: Cooling stimulus starting at 35 C initial temperature

Interventions

Warming stimulus starting at 30 C initial temperature OTHER

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.

Individuals with diabetes; Individuals with lower limb amputations of diabetic etiology; Individuals with lower limb amputations of non-diabetic etiologies; Individuals without a diagnosis of diabetes

Warming stimulus starting at 32 C initial temperature OTHER

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.

Individuals with diabetes; Individuals with lower limb amputations of diabetic etiology; Individuals with lower limb amputations of non-diabetic etiologies; Individuals without a diagnosis of diabetes

Warming stimulus starting at 34 C initial temperature OTHER

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.

Individuals with diabetes; Individuals with lower limb amputations of diabetic etiology; Individuals with lower limb amputations of non-diabetic etiologies; Individuals without a diagnosis of diabetes

Warming stimulus starting at 35 C initial temperature OTHER

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.

Individuals with diabetes; Individuals with lower limb amputations of diabetic etiology; Individuals with lower limb amputations of non-diabetic etiologies; Individuals without a diagnosis of diabetes

Cooling stimulus starting at 30 C initial temperature OTHER

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.

Individuals with diabetes; Individuals with lower limb amputations of diabetic etiology; Individuals with lower limb amputations of non-diabetic etiologies; Individuals without a diagnosis of diabetes

Cooling stimulus starting at 32 C initial temperature OTHER

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.

Individuals with diabetes; Individuals with lower limb amputations of diabetic etiology; Individuals with lower limb amputations of non-diabetic etiologies; Individuals without a diagnosis of diabetes

Cooling stimulus starting at 34 C initial temperature OTHER

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.

Individuals with diabetes; Individuals with lower limb amputations of diabetic etiology; Individuals with lower limb amputations of non-diabetic etiologies; Individuals without a diagnosis of diabetes

Cooling stimulus starting at 35 C initial temperature OTHER

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; Individuals with lower limb amputations of diabetic etiology; Individuals with lower limb amputations of non-diabetic etiologies; Individuals without a diagnosis of diabetes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to ambulate without upper extremity aids
• 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

You may not qualify if:

• \- Have no residual limb ulcers

Sponsors & Collaborators

• VA Puget Sound Health Care System: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Glenn K Klute, PhD

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, CLiMB

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 10, 2025
• Study Start: April 28, 2011
• Primary Completion: August 9, 2013
• Study Completion: August 9, 2013
• Last Updated: October 10, 2025

Record last verified: 2025-10

Locations

US (1)