Skip to main content
OpenTrials
Completed

NCT Number: NCT05399771

Radiofrequency Hyperthermia Safety Study

This study will include 20 healthy subjects with intact skin on their lower legs that meet inclusion criteria. Participants will serve as their own control, by heating one leg and not the other. The radiofrequency device consists of a 4 by 6 inch heating pad connected to a temperature controller. Subjects will receive weekly treatments for 4 weeks, and will be re-evaluated 4 weeks after the last treatment to assess any tissue changes that continue after the treatments have concluded.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Blood Flow Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Soft Tissue Injuries Wound Heal Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

About this study

This study will include 20 healthy subjects with intact skin on their lower legs that meet inclusion criteria below. Participants will serve as their own control, by heating one leg and not the other. The radiofrequency device consists of a 4 by 6 inch heating pad connected to a temperature controller. The pad will be applied to the back of the leg and will covered using a compression stocking. The other leg will receive a pad and compression stocking, but radiofrequency will not be applied (no heating).

At the first visit, subjects will be asked to fill out a healthcare questionnaire. With each weekly treatment, subjects will be evaluated to assess how their legs feel on a scale of 1-10, with 1 being no discomfort and 10 being intense pain. Their legs will be photographed before and after radiofrequency MH to examine any visible changes to the tissue. Study team will then use a PeriScan PIM 3 System Laser Doppler scanning for blood perfusion before the Thermofield treatment. The radiofrequency will be set to achieve 40°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 40°C, and the treatment time with consistent temperature application will be 30 minutes. Study team will then use a PeriScan PIM 3 System Laser Doppler scanning for blood perfusion after the Thermofield treatment ends. Study team will take thermal imaging photographs of the treatment area following each treatment.

Subjects will receive weekly treatments for 4 weeks, and will be re-evaluated 4 weeks after the last treatment to assess any tissue changes that continue after the treatments have concluded. Subjects will be excluded from the study if they develop any kind of intolerance to the MH treatment, like increased pain or unexpected skin changes. If they receive a significant injury or wound that is not due to the study, such that the skin of the lower leg is no longer intact, they will be excluded from the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • Healthy
  • 20<BMI<40

Exclusion criteria

  • Pregnant, nursing or child bearing potential
  • Active infections of the skin in the lower leg
  • Open or healing wounds on the lower leg
  • Autoimmune disorder
  • 40<BMI <20
  • History of blood clots
  • History of lower limb edema
  • Tattoos and metal hardware in the leg

Treatment and study plan

Laser Doppler

Device

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.

Other names: PeriScan PIM 3 System Laser Doppler

Radiofrequency Heating System

Device

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.

Other names: Thermofield

Thermal Imaging

Device

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

Healthcare Questionnaire & Measurement

Other

A survey tool created to collect info from participants including:

  • Name
  • Age
  • Weight/ height
  • Pregnant or nursing?
  • History of blood clots?
  • Any wound healing problems?
  • Any active open wounds on the legs?
  • Any autoimmune disorders?
  • Phone number
  • Email address

A measurement of the participants calf will be taken as well using a measuring tape.

Primary outcomes

  1. Mean Temperature Change- Skin Evaluation on Leg With Device

    Time frame: week 1

    To help determine safety during and after dermal application for generating elevated temperatures

  2. Mean Temperature Change- Skin Evaluation on Leg With Device

    Time frame: week 2

    To help determine safety during and after dermal application for generating elevated temperatures

  3. Mean Temperature Change- Skin Evaluation on Leg With Device

    Time frame: week 3

    To help determine safety during and after dermal application for generating elevated temperatures

  4. Mean Temperature Change- Skin Evaluation on Leg With Device

    Time frame: week 4

    To help determine safety during and after dermal application for generating elevated temperatures

  5. Mean Change in Blood Perfusion Assessment - mL/kg/Min

    Time frame: week 1

    Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied.

    Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min)

  6. Blood Perfusion Assessment - mL/kg/Min

    Time frame: week 2

    Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied.

    Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min)

  7. Blood Perfusion Assessment - mL/kg/Min

    Time frame: week 3

    Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied.

    Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min)

  8. Blood Perfusion Assessment - mL/kg/Min

    Time frame: week 4

    Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied.

    Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min)

  9. Blood Perfusion Assessment - mL/kg/Min

    Time frame: week 8

    Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied.

    Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min)

  10. Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment

    Time frame: week 1

    A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.

  11. Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment

    Time frame: week 2

    A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.

  12. Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment

    Time frame: week 3

    A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.

  13. Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment

    Time frame: week 4

    A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.

  14. Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment

    Time frame: week 8

    A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used.

  15. Safety: Number of Blister Formations

    Time frame: From week 1 through week 8

    Cumulative number of blisters formed across all participants during weekly sessions from week 1 to 8 is reported in the data table.

  16. Safety: Significant Changes in Redness

    Time frame: from week 1 through week 8

    Number of participants with significant changes in redness that required intervention.

Secondary outcomes

  1. Number of Participants Who Attended the Session

    Time frame: week 1

    The number of participants who attend hyperthermia sessions will be documented.

  2. Number of Participants Who Attended the Session

    Time frame: week 2

    The number of participants who attend hyperthermia sessions will be documented.

  3. Number of Participants Who Attended the Session

    Time frame: week 3

    The number of participants who attend hyperthermia sessions will be documented.

  4. Number of Participants Who Attended the Session

    Time frame: week 4

    The number of participants who attend hyperthermia sessions will be documented.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • thermofield

Registry information

Official study title

Radiofrequency Hyperthermia Safety Study (RHySS)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2022
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.