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NCT07215442 · ClinicalTrials.gov registry record · NA
Skin Temperature Perception and Prosthetic Thermoregulation
A NA study of Diabetes (DM) and Lower Limb Amputation Below Knee, sponsored by VA Puget Sound Health Care System.
- Completed
- Registry status
- NA
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT07215442: Completed NA study of Diabetes (DM) and Lower Limb Amputation Below Knee, sponsored by VA Puget Sound Health Care System.
NCT07215442 is a NA study of Diabetes (DM) and Lower Limb Amputation Below Knee that has completed, run by VA Puget Sound Health Care System. The registered enrollment target is 56 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07215442, a NA study of Diabetes (DM) and Lower Limb Amputation Below Knee, has completed, sponsored by VA Puget Sound Health Care System.
- COMPLETED
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The thermal perception threshold is the difference between the initial temperature and the temperature at which the participant detected the thermal stimulus
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 |
What the finished NCT07215442 record still lists
NCT07215442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
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.
NCT07215442 reports a single indexed study location in Washington.
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.
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).
Who is sponsoring clinical trial NCT07215442?
This trial is sponsored by VA Puget Sound Health Care System, which has 16 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT07215442's enrollment target sits among peer trials
56 1262nd of 2000 higher than 737 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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