Lower Limb Amputation Below KneeNCT07215442
Skin Temperature Perception and Prosthetic Thermoregulation
A study testing Warming stimulus starting at 30 C initial temperature, Warming stimulus starting at 32 C initial temperature and Warming stimulus starting at 34 C initial temperature in people with Lower Limb Amputation Below Knee and Diabetes (DM), run by VA Puget Sound Health Care System at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Amputation Below Knee, Diabetes (DM), Skin Temperature Change
- What is being tested?
- Warming stimulus starting at 30 C initial temperature, Warming stimulus starting at 32 C initial temperature and Warming stimulus starting at 34 C initial temperature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2011to 9 Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Cognitively aware Additional Inclusion Criteria for Individuals with Lower Limb Amputation
- Have been fit with a prosthesis
- Have used a prosthesis for at least six months
Show all 9Show fewer
- Wear the prosthesis for at least four hours per day by self-report
- Exclusion Criteria for Individuals with Lower Limb Amputation:
- Have no residual limb ulcers
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division
Seattle, Washington, 98108
About this study
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.
Read the detailed description
This study will include four groups of participants including individuals with diabetes, individuals without a diagnosis of diabetes, individuals with lower limb amputations of diabetic etiology, and individuals with lower limb amputations of non-diabetic etiologies.
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
- Lower Limb Amputation Below Knee, Diabetes (DM), Skin Temperature Change, Vascular Reactivity
- Being tested
- Warming stimulus starting at 30 C initial temperature, Warming stimulus starting at 32 C initial temperature, Warming stimulus starting at 34 C initial temperature, Warming stimulus starting at 35 C initial temperature, Cooling stimulus starting at 30 C initial temperature
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warming stimulus starting at 30 C initial temperatureOther
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 temperatureOther
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 temperatureOther
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 temperatureOther
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 temperatureOther
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 temperatureOther
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 temperatureOther
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 temperatureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Individuals without a diagnosis of diabetes | Other | Not described Receives: 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 | Not described Receives: 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 | Not described Receives: 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 | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start28 Apr 2011
- Primary completion9 Aug 2013
- Study completion9 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation Below KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Puget Sound Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Glenn K. Klute, PhD, VA Puget Sound Health Care System
- Investigators
- Glenn K Klute, PhD, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215442
- Sponsor's protocol ID
- 1587700
- Status last verified
- Oct 2025
- First submitted
- 26 Sep 2025
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Temperature Perception and Prosthetic Thermoregulation
- ClinicalTrials.gov ID
- NCT07215442
- Acronym / sponsor ID
- 1587700
- Conditions
- Lower Limb Amputation Below Knee, Diabetes (DM), Skin Temperature Change, Vascular Reactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- VA Puget Sound Health Care SystemUS federal agency
- Study start
- 28 Apr 2011 (actual)
- Primary completion
- 9 Aug 2013 (actual)
- Study completion
- 9 Aug 2013 (actual)
- First posted
- 10 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will include four groups of participants including individuals with diabetes, individuals without a diagnosis of diabetes, individuals with lower limb amputations of diabetic etiology, and individuals with lower limb amputations of non-diabetic etiologies.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Cognitively aware Additional Inclusion Criteria for Individuals with Lower Limb Amputation
- Have been fit with a prosthesis
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warming stimulus starting at 30 C initial temperatureA 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 | 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 temperatureA 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 | 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 temperatureA 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 | 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 temperatureA 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 | 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 temperatureA 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 | 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 temperatureA 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 | 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 temperatureA 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 | 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 temperatureA 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. | Other | 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 |
Primary outcome
Thermal perception threshold
Time frame: Day 1
The thermal perception threshold is the difference between the initial temperature and the temperature at which the participant detected the thermal stimulus
Skin blood flow difference
Time frame: Day 1
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn K Klute, PhD principal investigator
VA Puget Sound Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warming stimulus starting at 30 C initial temperature, Warming stimulus starting at 32 C initial temperature and Warming stimulus starting at 34 C initial temperature in people with Lower Limb Amputation Below Knee and Diabetes (DM), run by VA Puget Sound Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal perception threshold (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.