20
Participants
Start Date
June 27, 2022
Primary Completion Date
October 23, 2023
Study Completion Date
October 23, 2023
Laser Doppler
Study team will use a PeriScan PIM 3 System Laser Doppler to scan for blood perfusion before and after the Thermofield treatment. The PeriScan PIM 3 System is for non-invasive two-dimensional imaging of peripheral tissue.
Radiofrequency Heating System
The radiofrequency will be set to achieve 42°C/107.6°F) and maintain this temperature consistently during the application time. This temperature is mild and may feel like a drugstore heating pad. The device will be turned on on one leg and will remain off on the other. The time for the heating will be 36 minutes, during which participants will remain in a reclined position, with their legs elevated. The device takes approximately 6 minutes to achieve a tissue temperature of 42°C, and the treatment time with consistent temperature application will be 30 minutes.
Thermal Imaging
Study team will take thermal imaging photographs of the treatment area following each treatment.
Healthcare Questionnaire & Measurement
"A survey tool created to collect info from participants including:~1. Name~2. Age~3. Weight/ height~4. Pregnant or nursing?~5. History of blood clots?~6. Any wound healing problems?~7. Any active open wounds on the legs?~8. Any autoimmune disorders?~9. Phone number~10. Email address~A measurement of the participants calf will be taken as well using a measuring tape."
Atrium Health Wake Forest Baptist, Winston-Salem
thermofield
INDUSTRY
Wake Forest University Health Sciences
OTHER