Radiofrequency Hyperthermia Safety Study

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 27, 2022

Primary Completion Date

October 23, 2023

Study Completion Date

October 23, 2023

Conditions
Chronic PainSoft Tissue InjuriesWound HealBlood Flow
Interventions
DEVICE

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.

DEVICE

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.

DEVICE

Thermal Imaging

Study team will take thermal imaging photographs of the treatment area following each treatment.

OTHER

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."

Trial Locations (1)

27157

Atrium Health Wake Forest Baptist, Winston-Salem

All Listed Sponsors
collaborator

thermofield

INDUSTRY

lead

Wake Forest University Health Sciences

OTHER