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Radiofrequency Hyperthermia Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05399771
Recruitment Status : Recruiting
First Posted : June 1, 2022
Last Update Posted : May 8, 2023
Sponsor:
Collaborator:
Thermofield
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Soft Tissue Injuries Wound Heal Blood Flow Device: Laser Doppler Device: Radiofrequency Heating System Device: Thermal Imaging Other: Healthcare Questionnaire & Measurement Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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 no the other.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Radiofrequency Hyperthermia Safety Study (RHySS)
Actual Study Start Date : June 27, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Thermofield temperature controlled radiofrequency device
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).
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.
Other Name: PeriScan PIM 3 System Laser Doppler

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.
Other Name: Thermofield

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.





Primary Outcome Measures :
  1. Safety during and after dermal application for generating elevated temperatures - skin evaluations [ Time Frame: week 1 ]

    To demonstrate that application of the Thermofield temperature controlled radiofrequency device is safe for dermal application for generating elevated temperatures.

    Digital photographs will be taken of the skin before and after application of the radiofrequency device. Observations of blister formation will be recorded. Redness will be scored using digital colorimetry in the pre-treatment versus post-treatment photographs. Changes in redness will be measured and reported.


  2. Safety during and after dermal application for generating elevated temperatures - skin evaluations [ Time Frame: week 2 ]

    To demonstrate that application of the Thermofield temperature controlled radiofrequency device is safe for dermal application for generating elevated temperatures.

    Digital photographs will be taken of the skin before and after application of the radiofrequency device. Observations of blister formation will be recorded. Redness will be scored using digital colorimetry in the pre-treatment versus post-treatment photographs. Changes in redness will be measured and reported.


  3. Safety during and after dermal application for generating elevated temperatures - skin evaluations [ Time Frame: week 3 ]

    To demonstrate that application of the Thermofield temperature controlled radiofrequency device is safe for dermal application for generating elevated temperatures.

    Digital photographs will be taken of the skin before and after application of the radiofrequency device. Observations of blister formation will be recorded. Redness will be scored using digital colorimetry in the pre-treatment versus post-treatment photographs. Changes in redness will be measured and reported.


  4. Safety during and after dermal application for generating elevated temperatures - skin evaluations [ Time Frame: week 4 ]

    To demonstrate that application of the Thermofield temperature controlled radiofrequency device is safe for dermal application for generating elevated temperatures.

    Digital photographs will be taken of the skin before and after application of the radiofrequency device. Observations of blister formation will be recorded. Redness will be scored using digital colorimetry in the pre-treatment versus post-treatment photographs. Changes in redness will be measured and reported.


  5. Safety during and after dermal application for generating elevated temperatures - skin evaluations [ Time Frame: week 8 ]

    To demonstrate that application of the Thermofield temperature controlled radiofrequency device is safe for dermal application for generating elevated temperatures.

    Digital photographs will be taken of the skin before and after application of the radiofrequency device. Observations of blister formation will be recorded. Redness will be scored using digital colorimetry in the pre-treatment versus post-treatment photographs. Changes in redness will be measured and reported.


  6. Safety during and after dermal application for generating elevated temperatures - Blood Perfusion Assessment [ 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)


  7. Safety during and after dermal application for generating elevated temperatures - Blood Perfusion Assessment [ 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)


  8. Safety during and after dermal application for generating elevated temperatures - Blood Perfusion Assessment [ 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)


  9. Safety during and after dermal application for generating elevated temperatures - Blood Perfusion Assessment [ 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)


  10. Safety during and after dermal application for generating elevated temperatures - Blood Perfusion Assessment [ 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)


  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.


Secondary Outcome Measures :
  1. The number of times that participants attend hyperthermia sessions [ Time Frame: week 1 ]
    The number of times that participants attend hyperthermia sessions will be documented.

  2. The number of times that participants attend hyperthermia sessions [ Time Frame: week 2 ]
    The number of times that participants attend hyperthermia sessions will be documented.

  3. The number of times that participants attend hyperthermia sessions [ Time Frame: week 3 ]
    The number of times that participants attend hyperthermia sessions will be documented.

  4. The number of times that participants attend hyperthermia sessions [ Time Frame: week 4 ]
    The number of times that participants attend hyperthermia sessions will be documented.

  5. The number of times that participants attend hyperthermia sessions [ Time Frame: week 8 ]
    The number of times that participants attend hyperthermia sessions will be documented.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05399771


Contacts
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Contact: Caleb Suggs, BS 336.713.4339 csuggs@wakehealth.edu

Locations
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United States, North Carolina
Atrium Health Wake Forest Baptist Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Caleb Suggs, BS    336-713-4339    csuggs@wakehealth.edu   
Principal Investigator: Nicole Levi, PhD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Thermofield
Investigators
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Principal Investigator: Nicole Levi, PhD Atrium Health Wake Forest Baptist
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT05399771    
Other Study ID Numbers: IRB00075221
First Posted: June 1, 2022    Key Record Dates
Last Update Posted: May 8, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wake Forest University Health Sciences:
mild hyperthermia
Additional relevant MeSH terms:
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Chronic Pain
Hyperthermia
Fever
Soft Tissue Injuries
Pain
Neurologic Manifestations
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries