Radiofrequency Hyperthermia Safety Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Radiofrequency Hyperthermia Safety Study (RHySS)

Conditions
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Chronic Pain, Soft Tissue Injuries, Wound Heal, Blood Flow

Intervention / Treatment
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* Device: Laser Doppler
* Device: Radiofrequency Heating System
* Device: Thermal Imaging
* Other: Healthcare Questionnaire & Measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermofield temperature controlled radiofrequency device<br>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<br>* 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.<br>* Other names: PeriScan PIM 3 System Laser Doppler;Device: Radiofrequency Heating System<br>* 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.<br>* Other names: Thermofield;Device: Thermal Imaging<br>* Study team will take thermal imaging photographs of the treatment area following each treatment.<br>Other: Healthcare Questionnaire & Measurement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety during and after dermal application for generating elevated temperatures - skin evaluations | 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. | week 1 | 
| Safety during and after dermal application for generating elevated temperatures - skin evaluations | 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. | week 2 | 
| Safety during and after dermal application for generating elevated temperatures - skin evaluations | 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. | week 3 | 
| Safety during and after dermal application for generating elevated temperatures - skin evaluations | 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. | week 4 | 
| Safety during and after dermal application for generating elevated temperatures - skin evaluations | 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. | week 8 | 
| Safety during and after dermal application for generating elevated temperatures - Blood Perfusion Assessment | 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 | 
| Safety during and after dermal application for generating elevated temperatures - Blood Perfusion Assessment | 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 | 
| Safety during and after dermal application for generating elevated temperatures - Blood Perfusion Assessment | 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 | 
| Safety during and after dermal application for generating elevated temperatures - Blood Perfusion Assessment | 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 | 
| Safety during and after dermal application for generating elevated temperatures - Blood Perfusion Assessment | 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 | 
| Comfort level scores of participants receiving hyperthermia treatment | 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 | 
| Comfort level scores of participants receiving hyperthermia treatment | 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 | 
| Comfort level scores of participants receiving hyperthermia treatment | 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 | 
| Comfort level scores of participants receiving hyperthermia treatment | 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 | 
| Comfort level scores of participants receiving hyperthermia treatment | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of times that participants attend hyperthermia sessions | The number of times that participants attend hyperthermia sessions will be documented. | week 1 | 
| The number of times that participants attend hyperthermia sessions | The number of times that participants attend hyperthermia sessions will be documented. | week 2 | 
| The number of times that participants attend hyperthermia sessions | The number of times that participants attend hyperthermia sessions will be documented. | week 3 | 
| The number of times that participants attend hyperthermia sessions | The number of times that participants attend hyperthermia sessions will be documented. | week 4 | 
| The number of times that participants attend hyperthermia sessions | The number of times that participants attend hyperthermia sessions will be documented. | week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild hyperthermia