Skin Temperature Perception and Prosthetic Thermoregulation (NCT07215442) | Clinical Trial Compass
CompletedNot Applicable
Skin Temperature Perception and Prosthetic Thermoregulation
United States56 participantsStarted 2011-04-28
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for All Participants:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has already been completed and was studying skin temperature perception and blood flow in people with below-knee amputation and diabetes, would it be worth asking the researchers or my care team whether the findings could change how my residual limb skin is monitored for temperature or vascular changes?
2This study looked at thermal perception thresholds, which means it was testing how well people can sense heat and cold through their residual limb — given that diabetes can already affect nerve sensation, what do the results suggest about the risks of skin injury from my prosthetic socket if I have reduced temperature sensitivity?
3The trial also measured skin blood flow differences, which relates to how well blood circulates in the residual limb — could the findings from this study help my doctor assess whether my own vascular health makes me more vulnerable to skin breakdown or poor healing where my prosthetic fits?
4Since diabetes affects both nerve function and blood vessel health in ways that are directly relevant to what this trial studied, should I be getting any specific baseline tests of my skin sensation or circulation before being fitted or refitted for a prosthetic?
5Are there any published or forthcoming results from this completed trial that my care team could review, and would those findings change any recommendations about prosthetic design or how often my residual limb skin should be checked for temperature-related problems?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.