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Skin Temperature Perception and Prosthetic Thermoregulation
NCT07215442 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- 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
Study Locations (1)
Washington
- VA Puget Sound Health Care System Seattle Division — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2011-04-28 |
| Est. Completion | 2013-08-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07215442
The ClinicalTrials.gov registry entry for NCT07215442 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Puget Sound Health Care System, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Diabetes (DM) appearing as the primary indexed condition, and to 5 interventions — of which Warming stimulus starting at 30 C initial temperature is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07215442 reports 1 study location spanning 1 distinct geographic area — top geographies include Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07215442 about?
NCT07215442 is a clinical study titled "Skin Temperature Perception and Prosthetic Thermoregulation". 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 "w...
What is the current status of trial NCT07215442?
This trial is currently completed. It is a NA study. The enrollment target is 56 participants. The study started on 2011-04-28. Estimated completion is 2013-08-09.
What conditions does trial NCT07215442 study?
This clinical trial studies the following conditions: Diabetes (DM), Lower Limb Amputation Below Knee, Skin Temperature Change, Vascular Reactivity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07215442?
The interventions under investigation include: 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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07215442?
This trial is sponsored by VA Puget Sound Health Care System, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07215442 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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