Radiofrequency Hyperthermia Safety Study

Chronic Pain Clinical Trial

Official title:

Radiofrequency Hyperthermia Safety Study (RHySS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05399771
• Other study ID #: IRB00075221
• Status: Completed
• Phase: N/A
• Start date: June 27, 2022
• Est. completion date: October 23, 2023

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 23, 2023
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Flow
• Chronic Pain
• Fever
• Hyperthermia
• Soft Tissue Injuries
• Wound Heal

Intervention

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.
• 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.
• 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: 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.

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Thermofield

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Temperature Change- Skin Evaluation on Leg With Device	To help determine safety during and after dermal application for generating elevated temperatures	week 1
Primary	Mean Temperature Change- Skin Evaluation on Leg With Device	To help determine safety during and after dermal application for generating elevated temperatures	week 2
Primary	Mean Temperature Change- Skin Evaluation on Leg With Device	To help determine safety during and after dermal application for generating elevated temperatures	week 3
Primary	Mean Temperature Change- Skin Evaluation on Leg With Device	To help determine safety during and after dermal application for generating elevated temperatures	week 4
Primary	Mean Change in Blood Perfusion Assessment - mL/kg/Min	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
Primary	Blood Perfusion Assessment - mL/kg/Min	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
Primary	Blood Perfusion Assessment - mL/kg/Min	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
Primary	Blood Perfusion Assessment - mL/kg/Min	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
Primary	Blood Perfusion Assessment - mL/kg/Min	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
Primary	Change in 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
Primary	Change in 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
Primary	Change in 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
Primary	Change in 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
Primary	Change in 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
Primary	Safety: Number of Blister Formations	Cumulative number of blisters formed across all participants during weekly sessions from week 1 to 8 is reported in the data table.	From week 1 through week 8
Primary	Safety: Significant Changes in Redness	Number of participants with significant changes in redness that required intervention.	from week 1 through week 8
Secondary	Number of Participants Who Attended the Session	The number of participants who attend hyperthermia sessions will be documented.	week 1
Secondary	Number of Participants Who Attended the Session	The number of participants who attend hyperthermia sessions will be documented.	week 2
Secondary	Number of Participants Who Attended the Session	The number of participants who attend hyperthermia sessions will be documented.	week 3
Secondary	Number of Participants Who Attended the Session	The number of participants who attend hyperthermia sessions will be documented.	week 4