Radiofrequency Hyperthermia Safety Study
Radiofrequency Hyperthermia Safety Study (RHySS)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Atrium Health Wake Forest Baptist
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
|
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:
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:
Study team will take thermal imaging photographs of the treatment area following each treatment.
A survey tool created to collect info from participants including:
A measurement of the participants calf will be taken as well using a measuring tape. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Temperature Change- Skin Evaluation on Leg With Device
Time Frame: week 1
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To help determine safety during and after dermal application for generating elevated temperatures
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week 1
|
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Mean Temperature Change- Skin Evaluation on Leg With Device
Time Frame: week 2
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To help determine safety during and after dermal application for generating elevated temperatures
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week 2
|
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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
|
week 3
|
|
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
|
week 4
|
|
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) |
week 1
|
|
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) |
week 2
|
|
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) |
week 3
|
|
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) |
week 4
|
|
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) |
week 8
|
|
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.
|
week 1
|
|
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.
|
week 2
|
|
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.
|
week 3
|
|
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.
|
week 4
|
|
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.
|
week 8
|
|
Safety: Number of Blister Formations
Time Frame: From week 1 through week 8
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Cumulative number of blisters formed across all participants during weekly sessions from week 1 to 8 is reported in the data table.
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From week 1 through week 8
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Safety: Significant Changes in Redness
Time Frame: from week 1 through week 8
|
Number of participants with significant changes in redness that required intervention.
|
from week 1 through week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Attended the Session
Time Frame: week 1
|
The number of participants who attend hyperthermia sessions will be documented.
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week 1
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Number of Participants Who Attended the Session
Time Frame: week 2
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The number of participants who attend hyperthermia sessions will be documented.
|
week 2
|
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Number of Participants Who Attended the Session
Time Frame: week 3
|
The number of participants who attend hyperthermia sessions will be documented.
|
week 3
|
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Number of Participants Who Attended the Session
Time Frame: week 4
|
The number of participants who attend hyperthermia sessions will be documented.
|
week 4
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nicole Levi, PhD, Atrium Health Wake Forest Baptist
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00075221
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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